ES2316937T3 - CASSETTE TO CONTROL THE BLOOD MOVEMENT AND BLOOD COMPONENTS. - Google Patents

Abstract

An apparatus and method for extracorporeal blood separation and treatment. A cassette (1100) has integral flexible tubing which is routed above apertures or is otherwise exposed so that pressure can be applied to prevent fluid flow through a selected section of tubing. A hub within the cassette preferably connects sections of the tubing. A kit (1000) comprising the cassette (1100) and a separation bowl (10), UV chamber (700), and patient collection and return components (1193,1106,1194,1114) is adapted to be operated by a non-disposable tower (2000) which comprises peristaltic pumps with pump heads (1301,1302,1303,1304,1305) which engage flexible tubing loops (1120,1121,1122,1124) of the cassette, a cavity for receiving the UV chamber (700), and a centrifuge chamber (10), with all operations controlled by a programmed processor.

Description

Cassette to control blood movement and blood components

Technical Field of the Invention

The present invention generally relates to apparatus, to move and control the movement of blood and blood components, separate blood components, and treat blood of patients, and specifically to an apparatus to perform extracorporeal blood treatments.

Background of the invention

Several disease treatments require the drawing blood from a patient, process the one or more blood components, and return the processed components to a therapeutic effect Extracorporeal treatments require systems to safely draw blood from the patient, separate it in components, and return the blood or blood components to the patient. With the advancement of medical sciences it is possible treat patient blood in closed loop processes, returning to the patient his own blood treated in a medical treatment. A An example of such processes includes methods of external treatment of diseases in which there is a pathological increase of lymphocytes, such as cutaneous T-cell lymphoma or other diseases that They affect white blood cells. In such methods, the blood of the patient is irradiated with ultraviolet light in the presence of a chemical or an antibody. Ultraviolet light affects the binding between lymphocytes and the chemical or antibody that It inhibits the metabolic processes of lymphocytes.

Systems and methods have been proposed and used photophoresis that involve the separation of the leukocyte layer from blood, the addition of a photoactivatable medication, and the UV irradiation of the leukocyte layer before re-infusion to the patient. Photophoresis Extracorporeal can be used to treat numerous diseases  including graft versus host disease, rheumatoid arthritis, progressive systematic sclerosis, onset of juvenile diabetes, inflammatory bowel disease and other diseases that consider that they are mediated by T cells or leukocytes, including cancer Systems and systems have also been proposed and used apheresis methods that involve the separation of blood into several components.

Additionally, it has also been proposed and used apheresis systems and methods that involve blood separation in several components, and also involve pumping systems and valves that are difficult to manufacture or operate. Systems and Previous methods of photophoresis and apheresis generally require discontinuous processes and therefore it takes several hours in treat a patient or get a sufficient amount of separate blood components. In addition, the systems are very manufacturing complexes, especially flow controllers of fluid and valve systems.

In known photophoresis systems, provides a disposable kit that is loaded in permanent equipment hardware. The disposable kit contains complex tubes that are used to carry blood fluids to and from various devices included in the kit, such as a centrifuge container, a irradiation chamber, and several bags to supply and / or collect blood fluids Known disposable kits often contain a cassette, or other controlling mechanism, to control the flow of blood fluids throughout the disposable kit as well as your entry and exit of the patient. Disposable kits are used. only once and must be replaced or discarded after Each treatment session. When performing a treatment process, the kit connects to the patient forming a closed loop system and the various devices of the disposable kit are loaded into a computer permanent used to move blood fluids through the kit disposable as necessary. Once loaded, the system Permanent blood movement moves blood fluids to through the fluid circuitry of the kit.

A very real advance in the systems would be achieved of photophoresis if the size could be reduced, the complexity of manufacturing, manufacturing costs, and tubes within the disposable kit, even at the cost of a more complex system of blood movement This is because the movement system of blood is permanent use equipment, while you have to use a new sterile disposable kit every time.

Known disposable photophoresis kits they are difficult and expensive to manufacture, especially the mechanisms of valves and pumping into the cassette. Additionally, systems and Photophoresis and previous apheresis methods generally require discontinuous processes and therefore take several hours to deal with a patient or getting a sufficient amount of fragments separate blood. A constant object is to reduce the time that it takes to complete a complete treatment session of photophoresis or apheresis. Another object is to reduce the amount of blood to be taken from a patient and processed in processes in closed loop per photophoresis treatment session. Other object is to increase the amount of white blood cell yield or get  a cleaner cut of a white blood cell layer whole processed. Another object is to reduce costs and complexity associated with the manufacture of disposable kits used.

The characteristics of the present invention that are known from US 5 653 887 or EP 1208856 have been disclosed in the preamble of claim 1 attached.

Description of the invention

These and other objects are achieved with the present invention defined in claim 1. The present invention is refers to improving the device for photophoresis and apheresis in order to provide a less complex device, easier to manufacture, and a continuous process for separating enough fragments to treatment in order to greatly reduce the time of treatment.

The invention, in one aspect, includes a cassette to control the movement of fluids during a session of extracorporeal blood treatment, including the cassette a rigid plastic housing that has a top section and a lower section, together forming the upper sections and inferior an internal space; a cube within the internal space; flexible tubes connected to the hub; tube formed loops flexible, each of the loops adapted to hook a head peristaltic pump; and a hole and three sections of tube flexible running through the hole so that the fluid flow to through the sections can be closed by the pressure exerted in the sections A cube is preferably included within the housing to connect the sections of the flexible pipes. He bucket can be molded with the lower section in embodiments where the accommodation has an upper section and a section lower. In the most preferred embodiments, the hub connects Five sections of flexible tubes. In other embodiments, the accommodation can be a piece, considered superior because the bottom side is completely open or has holes or openings through which one or more actuators can exert pressure against the hose to selectively close the flow of fluid at appropriate times during photophoresis processes or apheresis, providing the lower side of the housing, or the superior housing, resistance against pressure exerted by the actuator head, closing a molded occluder bar, the bar and The actuator jointly the tube to prevent fluid flow. The occluder bar crosses three exposed sections of tube flexible, preferably at an approximately right angle, to the most efficient closure of the flow in the tube. In realizations where the rigid plastic housing has been formed of a section upper and lower that together form an internal space, the bottom section would preferably have the hole or holes to access, by the actuator or actuators, the section Exposed tube above the hole or holes. One realization preferred has five tube loops, five holes for five actuators, and a wider hole for three actuators. He Cassette housing can be formed very efficiently by mounting a  set of hoses in a lower section, pressing the tubes to U-routing guides, including a filter and hub assembly if not molded into upper sections or lower, and then simply snapping in upper section in the lower section.

A cassette that is not part of the invention it has one or more surface molded edges that are sized to receive a recordable smart card in the that identification data is recorded electronically, and that the operator easily pulls out when the sterile container containing the kit including the cassette opens and prepares to be installed in the tower permanent. The smart card is placed in a port of Read-write in the tower. The data of the Smart card can be used to verify that the kit is the right model, for example, and the smart card too can be used to record specific data of the procedure, just like all operator parameters and keystrokes, and analogues

A method of making the cassette that is not part of the invention includes molding a plastic upper section rigid with edges on a lower side, running edges as occluder bars, for example, and mold a lower section with holes and guides for the hoses, and then direct the tube through the guides, crossing the edges, and joining subsequently the upper and lower sections so that the tube sections that cross the edges are exposed to Through the holes The bucket can be molded in the section bottom, and the tube sections can be joined before placing the upper section of the cassette housing in the lower section, and subsequently they are preferably mounted by jump.

Brief description of the drawings

The invention is described in detail with with respect to the accompanying drawings, which illustrate an embodiment of the new device.

Figure 1 is a schematic representation of a disposable kit for use in photophoresis therapy that performs characteristics of the present invention.

Figure 2 is an elevated perspective view of an embodiment of a cassette to control fluid flow in the disposable photophoresis kit of figure 1.

Figure 3 is an exploded view of the cassette of figure 2.

Figure 4 is a top view of the cassette of figure 2 with the cover removed and representing circuitry internal tubular

Figure 5 is a bottom view of a cassette cover of figure 2.

Figure 6 is an elevated perspective view. of a filter set.

Figure 7 is a bottom perspective view. of the filter assembly of figure 6.

Figure 8 is an exploded view of the assembly of filter in figure 6.

Figure 9 is a perspective view rear of the filter assembly of figure 6.

Figure 10 is a schematic representation of the filter assembly of figure 6 coupled to sensors pressure and a data processor.

Figure 11 is a front view of a camera irradiation

Figure 12 is a longitudinal side view of the irradiation chamber of Figure 11.

Figure 13 is a cross-sectional side view of the irradiation chamber of figure 11.

Figure 14 is a sectional view of a section of the first plate and the second plate before joining together  to form the irradiation chamber of figure 11.

Figure 15 is a dimensional end view cut from the irradiation chamber of figure 11.

Figure 16 is a perspective view of the irradiation chamber of figure 11 placed inside a UVA light set.

Figure 17 is an elevated perspective view. of a permanent tower system for use in conjunction with a kit disposable to facilitate a photophoresis therapy session.

Figure 18 is a cross-sectional view. of the photoactivation chamber, without a set of UVA light, used in the tower system of figure 17.

Figure 19 is a cross-sectional view. of the centrifugal chamber used in the tower system of the figure 17.

Figure 20 is an electrical diagram of the leak detection circuit arranged in the chamber photoactivation of figure 18.

Figure 21 is an electrical diagram of the leak detection circuit arranged in the centrifugal chamber of Figure 19

Figure 22 is an elevated perspective view. of the fluid flow control cover of the tower system of figure 17.

Figure 23 is a perspective view bottom of the control cover of figure 22.

Figure 24 is an exploded view of the control cover of figure 22.

Figure 25 is a perspective view. top of the control cover of figure 22 with the cassette Figure 2 loaded on top.

Figure 26 is a flow chart of a Photophoresis treatment process.

Figure 27 is a flow circuit scheme of fluid used when performing the treatment process of the figure 26.

Figure 28 is a perspective view top of a peristaltic pump.

Figure 29 is a sectional side view cross section of the peristaltic pump of figure 28.

Figure 30 is a perspective view. upper rotor of the peristaltic pump of figure 29.

Figure 31 is a bottom view in rotor perspective of figure 30.

Figure 32 is a top view of the pump peristaltic of Figure 28.

Figure 33 is a top view of the pump peristaltic of Figure 28 in a loading position and near the cassette of figure 2.

Figure 34 is an electrical diagram of the infrared communication port circuit.

Figure 35 illustrates a centrifuge container and a rotating frame.

Figure 36 is a dimensional view of the container of figure 35.

Figure 37 is an exploded view of the container of figure 36.

Figure 38 represents a sectional view cross section of the container of figure 36 along the line XIX-XIX.

Figure 39A represents a sectional view. cross section of a connecting sleeve in position with a connector of lumen of the container of figure 38 along the line XX.

Figure 39B represents another sectional view. cross section of a connecting sleeve in position with a connector of lumen of the container of figure 38.

Figure 40 represents a sectional view transverse of the upper core of the container of Figure 37.

Figure 41 represents a dimensional view of the upper core and upper plate of Figure 37.

Figure 42 represents a bottom view of the upper core of figure 41.

Figure 43A represents a dimensional view exploded from the lower core and a lower plate of the vessel of figure 37.

Figure 43B represents a sectional view. dimensional cross section of the lower core and a lower plate of the container of Figure 43A joined together.

Figure 44 represents a side view exploded from the lower nucleus and a lower plate of the figure 43A.

Figure 45 represents a dimensional view of a set of ducts.

Figure 46 represents a dimensional view of the connection sleeve of Figure 45.

Figure 47 represents a dimensional view of one end of the duct assembly of figure 45.

Figure 48 represents a dimensional view of an anchor end of the present invention.

Figure 49 represents a side view in cross section of an anchor end.

Figure 50 represents a sectional view transverse horizontal of an anchor end taken along of line XXI.

Figure 51 illustrates a dimensional view of the rotating frame of figure 35.

Figure 52 is an enlarged view of a support for an external conduit.

Figure 53 represents a container alternative, taking the cross section the same as the represented in figure 38.

Figure 54 represents an upper core alternative.

Figure 55 represents a connection sleeve alternative.

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Ways to implement the invention

The outline of the written description is the next:

I. Disposable photophoresis kit

TO.

Cassette to control fluid flow

one.

Filter set

B.

Irradiation chamber

C.

Centrifuge container

one.

Drive tube

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II. The permanent tower system

TO.

Photoactivation camera

B.

Centrifugal chamber

C.

Fluid flow control cover

one.

Cassette Fixation Mechanism

2.

Automatic loading peristaltic pumps

D.

Infrared communication

III. Photophoresis treatment process.

The previous outline is included to facilitate the understanding of the characteristics of the present invention. He outline does not limit the present invention and it is not intended that categorize or limit any aspect of the invention. Inventions are described and illustrated in sufficient detail for experts in this technique they can make them and use them easily. But nevertheless, various alternatives, modifications, and improvements will be easily evident without departing from the scope of the invention defined in the claims. Specifically, although the invention is described in the context of a disposable kit and permanent system of blood movement for use in photophoresis therapy, some aspects of the invention are not limited thereto and are applicable to kits and systems used to carry out other therapies, such as apheresis or any other blood treatment therapy extracorporeal

1. Disposable photophoresis kit

Figure 1 illustrates a photophoresis kit disposable 1000. A new sterile disposable kit must be used for Each therapy session. In order to facilitate the circulation of fluids through photophoresis kit 1000, and treating fluids blood circulating through it, the photophoresis kit 1000 is installed in 2000 permanent tower system (figure 17). The 1000 photophoresis kit installation in the 2000 tower system It is described in detail below.

The 1000 photophoresis kit includes a cassette 1100, a centrifuge vessel 10, an irradiation chamber 700, 1125 hematocrit sensor, 1195 removable data card, treatment bag 50, and plasma collection bag 51. The kit of photophoresis 1000 also includes a saline connection peak 1190 and 1191 anticoagulant connection peak to connect respectively saline bags and anticoagulant fluid (not represented). The 1000 photophoresis kit has all the tubes and necessary connectors to connect all the fluid devices and route fluid circulation during a session of photophoresis treatment. All tubes are flexible tubes Sterile medical quality. 1192 three-port connectors are available in various positions for the introduction of fluids in the tubes, if required.

1193 needle adapters and 1194 to connect the 1000 photophoresis kit respectively to needles to aspirate whole blood from a patient and return the blood fluids to the patient. Alternatively, the kit 1000 photophoresis may be adapted to use a single needle to take whole blood from the patient and return the fluids blood to the patient. However, a kit of two is preferred needles because of the ability to simultaneously take blood whole and return blood fluids to the patient. When a patient is connected to photophoresis kit 1000, a closed loop system.

Cassette 1100 acts as an organizer of tubes and a fluid flow router. Irradiation chamber 700 is used to expose blood fluids to UV light. The recipient of centrifuge 10 separates whole blood into its different components according to density. The treatment bag 50 is a bag of three holes and 1000 ml. A straight junction hole 52 is used to inject a photoactivable or photosensitive compound into the bag of treatment 50. The plasma collection bag 51 is a bag of two holes and 1000 ml. The treatment bag 50 and the bag of plasma collection 51 have an articulated shutter tube 53 which can be used for drainage, if necessary. The kit of photophoresis 1000 also includes hydrophobic filters 1555 and 1556 that are adapted to connect to 1550 and 1551 pressure transducers to filter 1500 by means of ventilation tubes 1552 and 1553 to monitor and control the pressures inside the tubes that connect the patient (figure 10). Monitoring the pressure contributes to ensure that the kit operates within safe pressure limits. The individual devices of the photophoresis kit 1000, and its operation, are explained in detail below.

A. Cassette to control fluid flow

Figure 2 represents a perspective view top of a disposable cassette 1100 according to the invention for regulate, pump and control the movement of blood fluids during a photophoresis treatment session. The cassette 1100 it has a 1101 housing that forms an internal space that acts as a box for its various internal components and circuitry tubular. Housing 1101 is preferably made of plastic. hard, but you can make any material properly rigid. Housing 1101 has a side wall 1104 and a upper surface 1105. The side wall 1104 of the housing 1101 It has tabs 1102 and 1103 that extend from it. During a photophoresis treatment, the cassette 1100 must be fixed to the cover 1200 of the 2000 tower system, as best illustrated in the Figure 25. Tabs 1102 and 1103 help to place and secure the cassette 1100 to cover 1200.

Cassette 1100 has fluid inlet tubes 1106, 1107, 1108, 1109, 1110, 1111, and 1112 to receive fluids in cassette 1100, fluid outlet tubes 1114, 1115, 1116, 1117, 1118, and 1119 to expel fluids from cassette 1100, and a tube of 1113 fluid inlet / outlet that can be used to introduce and expel fluids from cassette 1100. These inlet and outlet tubes of fluid the cassette 1100 is fluidly coupled to a treated patient, as well as the various devices of the 1000 photophoresis kit, such as the centrifuge vessel 10, the irradiation chamber 700, the treatment bag 50, the plasma collection bag 51, and the bags containing saline, anticoagulant fluid to form a extracorporeal closed loop fluid circuit (figure 27).

Pump tube loops 1120, 1121, 1122, 1123, and 1124 protrude from the side wall 1104 of the housing 1101. Pump tube loops 1120, 1121, 1122, 1123, and 1124 have been intended to facilitate the circulation of fluids throughout the kit 1000 photophoresis during therapy. More specifically, when cassette 1100 is fixed to cover 1200 for operation, each one of said pump tube loops 1120, 1121, 1122, 1123, and 1124 are loaded into a corresponding peristaltic pump 1301, 1302, 1303, 1304 and 1305 (figure 4). Peristaltic pumps 1301, 1302, 1303, 1304, and 1305 move the fluid through the respective pump tube loops 1120, 1121, 1122, 1123, and 1124 in one predetermined direction, thereby moving the fluid through 1000 photophoresis kit (figure 1) as required. The operation for automatic loading and unloading of 1301 peristaltic pumps, 1302, 1303, 1304, and 1305 are explained in detail below with with respect to figures 28-33.

Turning now to figure 3, cassette 1100 is Represents with housing 1101 in an awakened state. For facilitate illustration and description, tubular circuitry inside the housing 1101 is not illustrated in Figure 3. The internal tubular circuitry is illustrated in Figure 4 and is will explain in relation to her. Cassette 1100 has the set of filter 1500 placed in it and in fluid connection with the tube inlet 1106, outlet tube 1114, and one end of each of the pump tube loops 1120 and 1121. The filter assembly 1500 includes 1540 and 1542 ventilation chambers. The filter assembly 1500, and its operation, are explained in detail later with with respect to figures 6-10.

Housing 1101 includes deck 1130 and the base 1131. The cover 1130 has an upper surface 1105, a lower surface 1160 (figure 5), and a side wall 1104. The cover 1130 has holes 1132 and 1133 for cameras of 1540 and 1542 ventilation of the 1500 filter assembly can be extend through. The side wall 1104 has a plurality of 1134 tube slots to allow inlet tubes, tubes outlet, and pump loop tubes pass into the internal space of the 1101 housing for connection to the internal tubular circuitry located in it. Only a few tube slots 1134 are labeled in figure 3 to avoid numerical variegation. The tabs 1102 and 1103 are placed on the side wall 1104 so that they do not interfere with tube slots 1134. The cover 1130 has occlusion bars 1162 and 1162A that are extend from the bottom surface 1160 (figure 5). The bars of occlusion 1162 and 1162A are preferably molded in the lower surface 1160 of deck 1130 during its training.

The base 1131 has a plurality of supports of U-shaped tube 1135 extending upward from the upper surface 1136. The U-shaped tube supports 1135 keep inlet tubes, outlet tubes, the pump loop tubes, the filter assembly, and the circuitry internal tubular Only a few U-shaped brackets 1135 they are labeled in figure 3 to avoid motley numerical. Preferably, a U-shaped support 1135 is arranged at base 1131 in each position where a tube of inlet, outlet tube, or pump loop tube passes to through a tube groove 1134 in the side wall 1104. Male projections 1136 protrude from the upper surface 1136 of the 1131 base for coupling with corresponding female holes 1161 located on the lower surface 1160 of the deck 1130 (figure 5). Preferably, a male projection 1136 is located in or near each of the four base corners 1130 and near the 1500 filter. 1136 male projections mate with female holes 1161 to form a secure and snap-fit base 1131 with the cover 1130.

The base 1131 also includes a bucket 1140. The hub 1140 is a five way tube connector used to connect five tubes of the internal tubular circuitry. Preferably three holes 1137 are located near and surrounding three tubes that lead to hub 1140. Hub 1140 acts as a union centralized that can be used, in conjunction with actuators of compression 1240-1247 (figure 22), to steer fluids through photophoresis kit 1000 and to and from the patient. In addition to hub 1140, appropriate tube connectors, such as 1141 T-connectors and 1142 Y-connector, they are used to Obtain the desired paths of the hoses.

Five holes 1137 are located in the ground of the base 1130. Each hole 1137 is surrounded by a wall of hole 1138 that has slots 1139 to pass portions of the internal tubular circuitry through it. An elongated hole 1157 It is also arranged on the base floor 1131. Holes 1137 are located at base 1131 to align with actuators of corresponding compression 1243-1247 of the cover 1200 (figure 22). Hole 1157 is located at base 1131 to alignment with compression actuators 1240-1242 of cover 1200 (figure 22). Each hole 1137 is sized so that a single compression actuator 1243-1247 can be extended through it. The hole 1157 is sized so that three compression actuators 1240-1242 can be extended through it. The 1240-1247 compression actuators are used to close / occlude and open certain circuitry fluid passages internal tubular in order to facilitate or prohibit the flow of fluid along a desired path. When you want to have a certain open passage so that fluid can flow through it, the compression actuator 1240-1247 for said step It is in a lowered position. However, when you want to close a certain fluid passage so that fluid cannot flow to your through, the appropriate compression actuator is raised 1240-1247, extending the compression actuator 1240-1247 through hole 1137 or 1157 and compressing a portion of the flexible tubular circuitry against the lower surface 1160 (figure 5) of the cover 1130, closing Therefore said step. Preferably, occlusion bars 1163 and 1173 (figure 5) are placed on the lower surface 1160 for alignment with compression actuators 1240-1247 so that the portion of flexible tubes occluded is compressed against occlusion bar 1163 or 1173. Alternatively, the occlusion bar can be omitted or placed in the compression actuators themselves.

It is preferable that the cassette 1100 has a unique identifier that can communicate and transmit information to 2000 permanent tower system. The unique identifier is provided in order to ensure that the disposable photophoresis kit is compatible with the blood movement equipment on which you are loading, and that the photophoresis kit be able to carry out The desired treatment process. The unique identifier too It can be used as a means to ensure that the photophoresis kit Disposable be of a certain name or trademark. In the example illustrated, the unique identifier is made as a data card 1195 (figure 2) that is inserted into the receiving port of 2001 data card for the 2000 permanent tower system (figure 17). The 1195 data card has reading capabilities and writing and can store data related to therapy Treatment performed for future analysis. The unique identifier It can also take several forms, including, for example, a microchip that interacts with the blood movement team when the kit is loaded, a barcode, or a number of Serie.

The 1130 cover has a card holder data 1134 to hold the data card 1195 (figure 1). He 1134 data card holder includes four raised edges in a segmented rectangular shape to receive and hold the card of data 1195 to cassette 1100. The data card holder 1134 hold the 1195 data card in position by snapping by jump (figure 2).

The internal cassette tubular circuitry 1100 is will now explain with reference now to figures 1 and 4. At least a portion of the internal tubular circuitry is made preferably of flexible plastic tubes that can be closed exerting pressure without compromising the hermetic integrity of the tube. The base 1131 of the cassette 1100 is illustrated in Figure 4 of so that the internal tubular circuitry can be seen. The tubes of inlet 1107 and 1108 and outlet tube 1115 are intended for couple the cassette 1100 to the centrifuge container 10 (figure 1). More specifically, the outlet tube 1115 is intended for supply whole blood from cassette 1100 to the container of centrifuge 10, and inlet pipes 1107 and 1108 are provided respectively to return blood components of density lower and higher density blood components to the cassette 1100 to direct them through the photophoresis kit 1000. The lower density blood components may include, for example, plasma, leukocytes, platelets, leukocyte layer, or Any combination thereof. Density components Higher may include, for example, red blood cells. The tube of outlet 1117 and inlet tube 1112 fluidly couple the cassette 1100 to the 700 irradiation chamber. More specifically, the tube output 1117 is planned to supply a component lower untreated blood density, for example the layer leukocyte, to irradiation chamber 700 for exposure to photoenergy, while the inlet tube 1112 is planned to return the treated lower density blood component to cassette 1100 for additional address.

Inlet tube 1111 and outlet tube 1116 they attach the treatment bag 50 to the cassette 1100. The tube of exit 1116 is planned to supply a blood component of untreated low density, for example the leukocyte layer, at treatment bag 50. The outlet tube 1116 has a sensor hematocrit ("HCT") 1125 operatively connected to it for monitor the introduction of a high blood component density, such as red blood cells. The HCT 1125 sensor is a set photosensor and is operatively coupled to a controller. He HCT 1125 sensor sends a detection signal to the controller when red blood cells are detected in the outlet tube 1116 and the controller will perform the appropriate action. Inlet tube 1111 It is planned to bring the blood component back down untreated density from the treatment bag 50 to the cassette 1100 for additional address. Inlet pipes 1109 and 1110 are connected respectively to storage bags of saline and anticoagulant (not shown) by peaks 1190 and 1191 and are intended to supply saline and a fluid anticoagulant to cassette 1100 to further direct them to the patient.

The inlet / outlet tube 1113 and the outlet tube 1118 attach the plasma collection bag 50 to the cassette 1100. More specifically, the outlet tube 1118 administers a blood component, such as plasma, to the plasma collection bag 51. The inlet / outlet tube 1113 can be used to deliver red blood cells to the plasma collection bag 51 from the cassette 1100 or to return the blood component (s) that accumulates (n)
in plasma collection bag 51 to cassette 1100 for additional address. Inlet tube 1106 and outlet tubes 1119 and 1114 are coupled to a patient. Specifically, the outlet tube 1114 is intended to return treated blood, saline, untreated blood components, treated blood components, and other fluids to the patient. The inlet tube 1106 is intended to deliver untreated whole blood (and a predetermined amount of an anticoagulant fluid) from the patient to the cassette 1100 for direction and treatment within the photophoresis kit 1000. The outlet tube 1119 is intended specifically to supply an anticoagulant fluid to the inlet tube 1106. It is preferable that all tubes be sterile disposable medical grade tubes. Flexible plastic tubes are the most preferred.

Cassette 1100 has five pump tube loops 1120, 1121, 1122, 1123, and 1124 to move blood fluids throughout the cassette 1100 and photophoresis kit 1000. More specifically, the pump tube loop 1121 loads the pump. whole blood 1301 and introduces and removes, respectively, whole blood from the cassette 1100 by the inlet tube 1106 and the outlet tube 1115, passing through the filter 1500 along the entire path. The pump loop tube 1120 loads the return pump 1302 and moves blood fluids through the filter 1500 and brings them back to the patient through the outlet tube 1114. The pump loop tube 1122 loads the red blood cell pump 1305 and It takes red blood cells from the centrifuge container 10 and takes them to cassette 1100 via the inlet line 1108. The pump loop tube 1123 loads the anticoagulant pump 1304 and moves an anticoagulant fluid to the cassette 1100 by the inlet tube 1124 and takes it out of the cassette 1100 by the outlet tube 1119, which connects with the inlet tube 1106. The pump loop tube 1124 loads the recirculation pump 1303 and removes 1100 blood fluids, such as plasma, from the cassette, a through the treatment bag 50 and the irradiation chamber
700.

Each of the peristaltic pumps 1301-1305 is activated when necessary to perform photophoresis treatment therapy according to a embodiment of the method of the present invention described more forward in relation to figures 26-27. The 1301-1305 peristaltic pumps can operate a every time or in any combination. The bombs 1301-1305 work in conjunction with actuators of 1240-1247 compression to direct fluids through of desired paths of the photophoresis kit 1000. Some holes 1137 and 1157 are strategically located at base 1131 at length of the internal tubular circuitry for easy handling appropriate. Through the use of compression actuators 1240-1247, fluids can be directed to along any route or its combination.

1. The filter assembly

The 1500 filter, which is located inside the 1100 cassette as described above, illustrated in detail in figures 6-10. With reference first to figures 6 and 7, filter 1500 is fully illustrated mounted. Filter 1500 includes a filter housing 1501. The filter housing 1501 is preferably made of a plastic transparent or translucent medical quality. However the 1501 filter housing can be made of any material that Do not contaminate blood or other fluids flowing through it.

The 1501 filter housing has four fluid connection holes leaving it, namely a whole blood inlet port 1502, an outlet port of whole blood 1503, treated fluid inlet port 1504, and an outlet of treated fluid 1505. The holes 1502-1505 are tube connection holes standard doctors that allow fluid to connect medical tubes. The holes 1502-1505 contain, respectively, holes 1506, 1507, 1508 and 1509. Holes 1506, 1507, 1508 and 1509 extend through holes 1502, 1503, 1504 and 1505, forming fluid passages to the filter housing 1501 in the desired positions.

Holes 1502, 1503, 1504 and 1505 are also used to fix the 1500 filter inside the 1100 cassette. do so, holes 1502, 1503, 1504 and 1505 can hook U-shaped fasteners 1135 of cassette 1100 (figure 3). He filter housing 1501 also has a projection 1510 that is extends from the bottom surface of the floor 1518 of the accommodation. The projection 1510 fits into a guide hole of the base 1131 of cassette 1100 (figure 3).

With reference now to figure 8, the filter 1500 is illustrated in an awakened state. The filter housing 1501 is a set of two pieces including the roof 1511 and the base 1512. Ceiling 1511 is connected to base 1512 by known means in the art, such as ultrasonic welding, heat welding, adhesive application, or designing the ceiling 1511 and the base 1512 of so that a narrow adjustment occurs between the two. Although the filter housing 1501 is illustrated as a set of two parts, the filter housing 1501 can be a structure of One piece or a set of multiple pieces.

The base 1512 has a separation wall of chamber 1513 extending upward from a surface upper floor 1518 of the housing (figure 7). When the base 1512 and the roof 1511 are mounted, the upper surface 1515 of chamber separation wall 1513 contacts the surface roof bottom 1511, forming two chambers inside the filter housing, 1516 whole blood chamber and chamber filter 1517. No fluid can flow directly between the chamber of whole blood 1516 and filter chamber 1517.

The whole blood chamber 1516 is a substantially L-shaped chamber having a floor 1514. The whole blood chamber 1516 has a whole blood inlet hole 1519 and a whole blood outlet hole (not shown) in the ground 1514. The whole blood inlet hole 1519 and the whole blood outlet hole are located at or near the ends of the substantially L-shaped whole blood chamber 1516. The whole blood inlet hole 1519 forms a passage with the hole 1506 of the inlet port 1502 so that a fluid can flow into the whole blood chamber 1516. Similarly, the whole blood outlet hole (not shown) forms a passage with the hole 1507 of the outlet hole 1503 of so that whole blood chamber fluid can flow out
1516

The 1517 filter chamber has a 1520 floor. The 1520 floor has a 1521 raised edge that extends towards above. The raised edge 1521 is rectangular and forms a perimeter. Although the raised edge 1521 is rectangular in the embodiment illustrated, the raised edge 1521 can be in any way to condition that it forms a closed perimeter. Edge height raised 1521 is less than the height of the separation wall of chamber 1513. As such, when the ceiling 1511 and the base 1512 are mounted, there is space between the top of the raised edge 1521 and the lower surface of the roof 1511. The raised edge 1521  and the chamber separation wall 1513 form a ditch 1524 In between.

In order to facilitate the flow of fluid to through the filter chamber 1517, the floor 1520 of the chamber filter 1517 has a 1522 treated fluid inlet hole and a 1523 treated fluid outlet hole. The inlet hole of treated fluid 1522 is located outside the perimeter formed by the raised edge 1521 and forms a passage with hole 1508 of the inlet port 1504 so that a fluid can flow to the filter chamber 1517 from outside filter housing 1501. The 1523 treated fluid outlet hole is located within the perimeter formed by the raised edge 1521 and forms a step with the hole 1509 of the outlet hole 1505 so that a filter chamber fluid 1517.

The filter 1500 further includes an element of filter 1530. Filter element 1530 includes a frame 1531 which has 1532 filter media placed in it. The 1531 frame it has a 1534 neck that forms a filter inlet hole 1533. Filter element 1530 is placed in the filter chamber 1517 so that frame 1531 fits into trench 1524 and the neck 1534 surrounds the entrance hole of treated blood 1522. The filter inlet hole 1533 is aligned with the hole in treated fluid inlet 1522 so that the incoming fluid can flow freely through holes 1522 and 1533 to the chamber of filter 1517. Frame 1531 of filter element 1530 forms a tight fit with raised edge 1521. All the fluid that enters filter chamber 1517 through holes 1522 and 1533 must pass through filter medium 1532 in order to exit the filter chamber 1517 through the fluid outlet hole treated 1523. The filter medium 1532 preferably has a pore size of approximately 200 microns. Filter medium 1532 can be formed from woven mesh, such as polyester tissue.

The 1517 filter chamber also includes a 1540 filter ventilation chamber inside the 1511 ceiling. The 1540 filter ventilation chamber has 1541 gas ventilation in the form of a hole (figure 9). Since gas ventilation 1541 opens to the 1540 filter ventilation chamber which in turn opens the filter chamber 1517, the gases that accumulate inside the 1517 filter chamber they can escape through the gas ventilation 1541. Likewise, the whole blood chamber 1516 includes 1542 blood ventilation chamber inside the ceiling 1511. Blood ventilation chamber 1541 has ventilation of 1543 gas in the form of a hole. Since gas ventilation 1543 opens to the 1542 blood vent chamber which in turn opens to the chamber of whole blood 1517, the gases that accumulate in the 1516 whole blood chamber they can escape by the gas ventilation 1543.

Figure 10 is a top view of the filter 1500 which has 1550 and 1551 pressure sensors connected to gas holes 1541 and 1543. Pressure sensors 1550 and 1551 are preferably pressure transducers. The 1550 pressure sensor is connected to the 1541 gas vent by means of 1552 ventilation. 1552 ventilation pipes fit into the 1541 gas vent in order to form a tight fit and sealed. Since the 1541 gas vent opens to the chamber of 1540 filter vent which in turn opens to the chamber of filter 1517, the pressure in the ventilation tubes 1552 is the same than in the 1517 filter chamber. Measuring the pressure in the tubes of ventilation 1552, pressure sensor 1550 also measures the pressure inside the filter chamber 1517. Similarly, the sensor pressure 1551 is connected to the 1543 gas vent by the 1553 ventilation tube. The 1553 ventilation tubes fit in gas ventilation 1543 in order to form an adjustment tight and sealed and the pressure sensor 1551 measures the pressure inside the whole blood chamber 1516. The ventilation chamber of filter 1540 and blood ventilation chamber 1542 is extend through holes 1132 and 1133 of cassette 1100 when filter 1500 is placed (figure 2). This allows to monitor the pressure inside chambers 1516 and 1517 protecting it 1500 filter chamber time and fluid connections with she.

Pressure sensors 1550 and 1551 are coupled to controller 1554, which is a properly programmed processor. The 1554 controller can be a main processor used to move the entire system or it can be a separate processor coupled to a main processor. Pressure sensors 1550 and 1551 produce electrical output signals representative of pressure readings within chambers 1517 and 1516 respectively. Controller 1554 frequently or continuously receives data representing the pressure within chambers 1516 and 1517. Controller 1554 is programmed with values representing the desired pressures within chambers 1516 and 1517. Controller 1554 continuously analyzes data from pressure it receives from pressure sensors 1550 and 1551 to determine if the pressure readings are within a predetermined range of the desired pressure for chambers 1517 and 1516. The 1554 controller is also coupled to the whole blood pump 1301 and the return pump 1302. In response to the pressure data received from pressure sensors 1551 and 1550, controller 1554 is programmed to control the speed of the whole blood pump 1301 and the return pump 1302, thereby adjusting the rates of flow through pumps 1301 and 1301. In turn, the adjustment of said flow rates adjusts the pressure within the whole blood chambers 1 516 and filter chamber 1517 respectively. In this way, the pressure within the lines that take and return blood to the patient is maintained at levels
acceptable.

The operation of the 1500 filter during a photophoresis therapy session will now be explained in relation to Figures 1, 6 and 10. Although the operation of the filter 1500 is will describe in detail regarding the taking of whole blood from a patient and the return of a component of said whole blood to the patient after being treated, the invention is not limited to it. The 1500 filter can be used in connection with almost any fluid, including red blood cells, white blood cells, layer leukocyte, plasma, or their combination.

Whole blood pump 1601 takes blood of a patient who is connected to photophoresis kit 1000 by a needle connected to hole 1193. Speed Rotational whole blood pump is set so that the line pressure that the patient's whole blood takes is at a acceptable level. When taken from the patient, whole blood passes to cassette 1100 by means of the inlet pipe 1106. The tube of inlet 1106 is fluidly connected to inlet hole 1502 of filter 1500. Whole blood passes through hole 1506 from inlet hole 1502 and to the whole blood chamber in shape of L 1516. Whole blood enters chamber 1516 through the entry hole 1519 which is located on the ground 1514. When more whole blood enters chamber 1516, whole blood is spills along the ground 1514 until it reaches the hole of whole blood outlet (not illustrated) at the other end of the L-shaped whole blood chamber 1516. As explained previously, the outflow of whole blood forms a step with the hole 1507 of exit hole 1503. Whole blood that is inside chamber 1516 flows through the ground 1514, through from the whole blood outlet hole, to the 1503 exit hole, and exits filter 1500 through hole 1507.

When whole blood passes through the 1516 whole blood chamber, the gases that get trapped escape  In whole blood. These gases are collected in the chamber of blood ventilation 1542 and subsequently escape through the 1543 gas ventilation. Pressure sensor 1551 monitors continuously the pressure inside the blood chamber 1516 to through the 1553 vent tube and transmits pressure data corresponding to controller 1554. Controller 1554 analyzes the pressure data received and, if necessary, regulates the speed of the whole blood pump 1301, thereby adjusting the flow rate and pressure inside chamber 1516 and the tube of input 1106. The 1554 controller adjusts the pump speed to ensure that the pressure is within the pressure range wanted.

The whole blood then leaves the filter 1500 to through exit hole 1503 and exits cassette 1100 through the outlet tube 1115. Whole blood is then separated into components and / or treated as described in detail below. Before being returned to the patient, this treated fluid (that is, the treated blood or blood components) must be filtered. Untreated fluids, such as red blood cells, should also be filtered, and will undergo the subsequent filtration process. The treated fluid It is fed to filter chamber 1517 through hole 1508 of the inlet port 1504. The inlet port 1504 is connected by fluid to the pump loop tube 1120. The fluid treated enters the filter chamber 1517 through the hole of inlet 1522 and pass through the inlet hole of the 1533 filter of filter element 1530. The treated fluid fills the chamber of filter 1517 until it overflows on the frame 1531 of the filter 1530, which is fixed to the raised edge 1521. The fluid treated passes through filter media 1532. Filter media 1532 removes contaminants and other unwanted materials from the fluid treated, while facilitating the release of gases trapped from the treated fluid. The treated fluid that passes through of the filter medium 1532 is collected on the floor 1520 of the chamber of filter 1517 within the perimeter formed by the raised edge 1521. This treated fluid then passes to the exit hole of 1523 treated fluid and exits filter 1500 through the hole 1506 of the outlet hole 1502. The treated fluid is returned subsequently to the patient through the outlet tube 1114, which It is fluidly connected to the outlet hole 1502. The fluid treated is passed through the 1517 filter chamber and the tube of output 1114 by return pump 1302.

The gases trapped in the treated fluid escape and are collected in the 1540 filter ventilation chamber when the treated fluid flows through filter chamber 1517. These gases then escape from filter 1500 through ventilation gas 1541. Pressure sensor 1550 continuously monitors the pressure inside the filter chamber 1517 through the tube of ventilation 1552 and transmits pressure data corresponding to the 1554 controller. 1554 controller analyzes the pressure data received and compares them with the desired value and pressure range. If necessary, the 1554 controller regulates the pump speed return 1302, thereby adjusting the flow rate and pressure inside chamber 1517 and outlet tube 1114.

B. Irradiation chamber

Figures 11-16 illustrate in detail the irradiation chamber 700 of photophoresis kit 1000. With reference first to Figure 11, the irradiation chamber 700 It is formed by joining two plates, one front and one rear plate that preferably have a thickness of about 0.06 inch to about 0.2 inch, which are preferably made up of a ideally transparent material at the radiation wavelength electromagnetic In the case of ultraviolet A radiation, the Polycarbonate is considered very preferred, although it can be used Other materials such as acrylic. Likewise, it can be used many known joining methods and do not have to be explained here.

The first plate 702 has a first surface 712 and a second surface 714. In one embodiment preferred the first plate 702 has a first hole 705 in a first surface 712, in fluid communication with the second surface 714. The second surface 714 of the first plate 702 It has a high limit 726A defining an enclosure. The 726A limit preferably extends substantially perpendicular to the second surface 714 (ie approximately 80-100 degrees). From the second surface 714 (preferably substantially perpendicularly) extend elevated partitions 720A. The 726A limit surrounds the partitions 720A. One end of each partition 720A extends and contacts the limit 726A.

The second plate 701 has a first surface 711 and a second surface 713. In one embodiment preferred, the second plate 701 preferably has a second hole 730 on a first surface 711, in communication of fluid with the second surface 713. The second surface 713 of the back plate 701 has a high limit 726B which defines a enclosure. The limit 726B preferably extends so substantially perpendicular to the second surface 713 (it is say, approximately 80-100 degrees). From the second surface 713 (preferably substantially perpendicular) elevated partitions extend (720B). The 726B limit surround the 720B partitions. One end of each 720A partition is extend and contact a boundary side (726B).

The union of the second surfaces of the first and second plates results in a fluid-tight connection between the limits 726A and 726B thereby forming the limit 726. The partitions 720A and 720B also join forming a fluid-tight joint forming hence the partition 720. The boundary 726 forms an irradiation chamber 700 and together with the partitions 720 provides a path 710 having channels 715 for conducting fluid. The tour can be in coil, zig-zag, or dovetail. Currently a tour is preferred in
coil.

With reference to figures 11 and 12, the chamber of 700 irradiation includes a 710 coil travel path patient fluid, such as the white blood cell or blood cells white, from inlet port 705 to outlet port 730, that is, the 710 coil travel is in communication from fluid with inlet port 705 of front plate 702 and outlet hole 730 of back plate 701. Supplied patient fluid from cassette 1100 to inlet port 705 through the outlet tube 1117. After photoactivation and pass through the coil path 710, the treated fluid from the  patient is returned to cassette 1100 using the inlet tube 1112 (figures 1 and 4). The patient's fluid is moved by the pump of recirculation 1303. The effects of self -linking of the cells are reduce at the same time that the cells are photoactivated by the irradiation that hits both sides of the irradiation chamber 700.

Figure 11 depicts pin 740 and the recess 735 lining the two plates of the irradiation chamber before joining together in a sealed arrangement by RF welding, heat pulse welding, welding by solvent or adhesive bond. The union of the plates by union Adhesive and RF welding is preferable. The union of the plates Front and rear by RF welding is very preferred since the design of raised partitions 720 and perimeter 725 minimizes the flickering and allows a uniform application of RF energy. The positions of pin 740 and recess 735 can be inside the 710 coil travel or 710 coil travel. Figure 2 also represents a view of a camera of irradiation with the L axis. 180 degree rotation of the chamber 700 around the L axis gives the original camera configuration irradiation The irradiation chamber of the present invention It has C2 symmetry around the L axis.

With reference to figures 11, 13, and 16, the leukocyte enriched blood, plasma, and solution priming are distributed through inlet hole 705 of the front plate 702 of irradiation chamber 700 to channel 715. Channel 715 in irradiation chamber 700 is relatively "fine" (for example, on the order of approximately 0.04 inches as distance between two plates) in order to present a large surface area of leukocyte-rich blood upon irradiation and reduce the self-binding effects of relationships more low surface area / volume. The cross-sectional shape of channel 715 is substantially rectangular (for example, rectangular, rhomboid or trapezoidal) which has as its long side the distance between partition 720 and the distance between the plates as Its short side. The shape of the cross section is designed to  Optimum irradiation of cells that pass through channel 715. Although a 710 coil travel is preferred in order to avoid or minimize areas of stagnant flow, others are contemplated dispositions

The irradiation chamber 700 allows the efficient activation of photoactivatable agents by irradiation from  a set of lights, such as the two banks of UVA lamps PHOTOSETTE® (758) for activation (figure 16). Plate irradiation and the UVA light assembly (759) are designed to be used in a position where edge 706 is oriented towards below and edge 707 points up. In this orientation, the fluids entering the inlet port 705 can exit the exit hole 730 with the help of gravity. In the most preferred embodiment, the irradiation of both sides of the irradiation chamber takes place simultaneously allowing the At the same time the easy removal of the camera. Light set UVA 759 is located inside the UV 750 chamber of the system permanent tower 2000 (figures 17 and 18).

The fluid path of the chamber of irradiation forms loops to form two or more channels where it circulates  leukocyte enriched blood during photoactivation by UVA light Preferably, the irradiation chamber 700 has between 4 and 12 channels. More preferably, the irradiation chamber has 6 to 8 channels Most preferably, the irradiation chamber It has 8 channels.

Figure 14 depicts cut views of the irradiation chamber Channels 715 of the coil route 710 are formed by the union of the raised partition 720 and the perimeter 726 of the plates.

The irradiation chamber can be made of a biocompatible material and can be sterilized by known methods such as heating, radiation exposure or treatment with ethylene oxide (ETO).

Now the method of irradiating cells will be explained using irradiation chamber 700 during treatment extracorporeal cells with electromagnetic radiation (UVA) to use in the treatment of a patient (such as to induce apoptosis in the cells and supply the cells to the patient). Preferably the treated cells will be white blood cells.

In one embodiment of this method, a photoactivable or photosensitive compound is first supplied to at least a portion of the blood of a recipient before extracorporeal treatment of the cells. The photoactivable or photosensitive compound can be administered in vivo (for example, orally or intravenously). The photosensitive compound, when administered in vivo , can be administered orally, but can also be administered intravenously and / or by other conventional routes of administration. The oral dose of the photosensitive compound may be in the range of about 0.3 to about 0.7 mg / kg, more specifically about 0.6 mg / kg.

When administered orally, the compound photosensitive can be administered at least about one hour before photophoresis treatment and no more than approximately three hours before the photophoresis treatment. Yes It is administered intravenously, the times would be shorter. Alternatively, the photosensitive compound can be administered. before or simultaneously with exposure to ultraviolet light. He photosensitive compound can be administered to whole blood or a fraction thereof as long as the white blood cells or Blood components receive the photosensitive compound. A portion of the blood could be processed first using methods known to substantially remove erythrocytes and the compound  photoactive can then be administered to the enriched fraction with leukocytes resulting. In one embodiment, the cells Blood include white blood cells, specifically, cells T.

The photoactivable or photosensitive compound can being able, in the case of some psoralens, to bind acids nuclei upon activation by radiation exposure electromagnetic of a preset spectrum, for example, light ultraviolet.

Photoactive compounds may include, although without limitation, compounds known as psoralens (or furocoumarins) as well as derivatives of psoralens such as described, for example, in United States Patent number 4,321,919 and U.S. Patent No. 5,399,719. The photoactivatable or photosensitive compounds that can be used include, but are not limited to, psoralen and derivatives of psoralenos; 8-methoxypsoralen; 4,5'8-trimethylpsoralen; 5-methoxy-psoralen; 4-methylpsoralen; 4,4-dimethylpsoralen; 4-5'- dimethylpsoralen; 4'-aminomethyl-4,5 ', 8-trimethylpsoralen; 4'-hydroxymethyl-4,5 ', 8-trimethylpsoralen; 4 ', 8-methoxypsoralen; and a 4 '- (omega-amino-2-oxa) alkyl-4,5 ', 8-trimethylpsoralen, including but not limited to 4 '- (4- amino-2-oxa) butyl-4,5 ', 8-trimethylpsoralen.  The photosensitive compound that can be used includes the derivative of psoralen, amotosalen (S-59) (Cerus, Corp., Concord, CA). See, for example, United States Patents Nos. 6,552,286, 6,469,052 and 6,420,570. The photosensitive compound which can be used includes 8-methoxypsoralen.

Methoxsalen is a natural photoactive substance found in the seed of Ammi majus (umbelliferous plant). It belongs to a class of compounds known as psoralens or furocoumarins. The chemical name is 9-methoxy-7H-furo [3,2-g] [1] -benzopyran-7-one. The drug formulation is a sterile liquid in a concentration of 20 mcg / ml in a 10 ml vial. See http: // www.therakos.com /TherakosUS/pdf/uvadexpi.pdf. Toxicological studies of extracorporeal photophoresis and different doses of UVADEX® and ultraviolet light in beagle dogs are found in the researcher's brochure.

Next, the blood portion of the subject, recipient's blood, or the blood of the donor to whom it has been administered the photoactive compound, it is treated by subjecting the portion from blood to photophoresis using ultraviolet light. The treatment of photophoresis can be carried out using ultraviolet light from Long wavelength (UVA) at a wavelength within the 320 to 400 nm range. However, such a range is not limiting, It is simply offered as an example. Light exposure ultraviolet during photophoresis treatment may have a duration of sufficient length for administration, for example, about 1-2 J / cm2 to the blood.

The photophoresis step is carried out in vitro by installing an irradiation chamber 700 in the photoactivation chamber 750 of the permanent tower system 2000 (Figures 17 and 18). In one embodiment, when the photophoresis step is carried out in vitro , at least a fraction of the treated blood is returned to the subject, recipient, or donor. The treated blood or the enriched leukocyte fraction treated (as the case may be) can be subsequently administered to the subject, recipient, or donor.

The photophoresis process consists of three phases including: 1) collecting a fraction of the white blood cell layer (enriched with leukocytes), 2) irradiation of the layer fraction leukocyte collection, and 3) reinfusion of white blood cells treated. This process will be explained later in more detail. Generally, whole blood is centrifuged and separated in the centrifuge container 10. A total of approximately 240 ml of leukocyte layer and 300 ml of plasma are separated and stored for UVA irradiation.

The plasma and leukocyte layer collected are mix with normal heparinized saline and UVADEX®. (8-water soluble methoxypsoraline). This mixture flows to a 1.4 mm thick layer through the chamber of irradiation of the present invention. The irradiation chamber 700 is introduced in the photoactivation chamber 750 of the system 2000 tower between two banks of PHOTOSETTE® UVA lamps (figure fifteen). UVA PHOTOSETTE® lamps radiate both sides of this transparent irradiation chamber at UVA 700, allowing the exposure to ultraviolet A light, producing medium exposure by lymphocyte of 1-2 J / cm2. After period of photoactivation, the cells are removed from the irradiation chamber 700.

The cells are removed by the action of gravity and the cells left in the chamber are displaced from the chamber with additional fluid selected from the group consisting of saline, plasma, and their combinations. For small patients, such as children (for example, less than 30 kg) or patients whose system vascular is easily overloaded with fluids, the amount of additional fluid used to wash the irradiation chamber will be preferably not more than 2X the volume of the camera, preferably no more than 1X the volume of the camera, more preferably no more than 0.5X the chamber volume 0.25X the camera volume The volume of treated cells is infused back to the patient.

For a description of systems and methods of similar photophoresis, see the State Patent Application United number 09 / 480,893. Also useful here are the methods and systems described in US Pat. Nos. 5,951,509, 5,985,914, 5,984,887, 4,464,166, 4,428,744, 4,398,906 and 4,321,919, and PCT publications numbers WO 97/36634 and WO 97/36581.

The effective amount of light energy supplied to biological fluids can be determined using the methods and systems described in US Pat. No. 6,219,584. In fact, the application of ECP to the various diseases described here may require an adjustment of the amount of light energy to optimize the treatment process.

In addition, the photosensitizing agent used in the ECP process can be removed before returning the biological fluid treated the patient For example, methoxsalene (UVADEX®) is used in the ECP process. Methoxsalen belongs to a group of compounds known as psoralens. Exposure to Methoxsalen U other psoralens may produce undesirable effects on the subject, recipient, or donor such as phototoxicity or other toxic effects associated with the psoralen and its decomposition products. By therefore, the psoralen, the derivatives of psoralen, or the psoralen decomposition products that can remain in the Biological fluid can be removed after UV exposure. A process for the extraction of biological fluids from psoralen is described in US Patent No. 6,228,995.

C. Centrifuge container

Methods and apparatus that separate fluid components are described, such as, for example, the components of a biological fluid by density or weight. Biological fluids encompass fluids that include, exist, or are used or administered to living organisms. In fact, biological fluids can include body fluids and their components, such as blood cells, plasma, and other fluids that include biological components, including living organisms such as bacteria, cells, or other cellular components. Biological fluids may also include whole blood or specific components of whole blood, including red blood cells, platelets, white blood cells, and precursor cells. In particular, it may be desirable to draw blood from a patient for treatment, such as, for example, extracorporeal treatment. It is to be understood, however, that several centrifugal processing apparatus can be used, and the specific example given here is simply for illustrative purposes. Other uses of separation techniques and apparatus may include other medical processes such as dialysis, chemotherapy, separation and removal of platelets, and separation and extraction of other specific cells. In addition, other types of separate fluids can be used that include a wide variety of non-medical uses, such as, for example, separation of oil and fluid components. The components used must not adversely affect the biological fluids or make them unsuitable for their intended uses, such as those described here, and can be made of any suitable material compatible with the uses described herein including, but not limited to plastic, polycarbonate, methacrylate methyl, styrene-acrylonitrile, acrylic, styrene, acrylonitrile or any other plastic. Where parts to be joined together and form a fluid tight seal are indicated, any suitable conventional means of joining the parts may be used, including, but not limited to, adhesives, ultrasonic welding or welding
RF

Several advantages can be achieved over centrifuges that use the conventional Latham container. He Latham vessel in the UVAR® XTS ™ system has a hole input that allows whole blood to enter the vessel, and an exit hole that allows the plasma and layer to exit leukocyte Having only two holes, limit the volume of leukocyte layer that can be collected per cycle. Every cycle it involves filling the container with whole blood; 2) centrifuge the plasma whole blood vessel, layer leukocyte, and red blood cells; 3) collect the leukocyte layer to treatment, 4) leave the container at rest; and 5) return the Plasma and red blood cells collected. This method of collecting leukocyte layer can be characterized as "discontinuous" since the volume of leukocyte layer required for irradiation treatment can only be collected after several cycles of leukocyte layer collection. Limited volume leukocyte layer collected per cycle results from blood cells accumulated reds left inside the container. So the globules accumulated reds that can only be emptied at the end of a leukocyte layer collection cycle is an inherent limitation of the Latham vessel.

The container described here has three ducts of separate fluids that can be used as an orifice of entrance and two exit holes. Fluid conduits additional allow 1) reduce the treatment time of the patient having continuous centrifugation throughout the entire process of leukocyte layer collection without having to stop spinning from the container for extracting accumulated red blood cells; 2) treat patients with a small volume of blood; upon returning continuously red blood cells collected from patients, these patients can lend more to medical treatments than require the use of the leukocyte layer or fractions thereof as extracorporeal photophoresis; 3) better separation of different  components of cell fractions within the leukocyte layer due to the longer spin time or rotation and 4) the capacity of separating high density fractions of red blood cells from blood whole This centrifuge container also provides the possibility of reduced treatment time for any medical procedure that requires the collection of layer fractions leukocyte of patients who lack substantially blood cells reds, such as extracorporeal photophoresis.

Figures 35 and 36 illustrate examples specific containers. The example illustrated in Figure 35 includes a 10A centrifuge container, duct assembly 860A, 910A frame and 918A stationary retention. The vessel of 10A centrifuge is in fluid communication with the duct external 20A of the duct assembly 860A. Cuff end bottom 832A (figure 46) of connection sleeve 500A is fixed to container 10A. The upper end of cuff 831A cuff of connection 500A is fixed to the external conduit 20A, connecting the external conduit 20A to container 10A and making communications of fluid from the outer conduit 20A to the container 10A. The fluid communications allow 800 fluid to be supplied through from the outer conduit 20A to the container 10A. You are also fluid communications also allow to take out of the container 10A fluid components separated 810 and 820 through the conduit external 20A. The container 10A and the frame 910A are adapted to rotate around the central axis 11A.

With reference to Figure 36, the container 10A includes an outer housing 100A, connection sleeve 500A, upper core 200A, lower core 201A, and housing floor 180A The outer housing 100A can be built from any suitable biocompatible material as previously described to illustrative effects in figure 36 the outer housing 100A It is made of clear plastic so that cores 200A and 201A are visible through. The outer housing 100A is connected to a accommodation floor 180A, which, in turn, includes projections 150A to lock the container 10A to a rotational device such as  the 900A rotational device. The container 10A is preferably of simplified construction and is easy to manufacture by molding or other known manufacturing processes, so that can be disposable or used for a limited number of treatments, and most preferably it is able to contain approximately 125 ml of fluid, possibly being pressurized said fluid. In alternative embodiments, the capacity Volumetric container may vary depending on the health of the patient and its permissible extracorporeal volume. The capacity of Container volume may also vary depending on the use of the container or the particular treatment for which the container. In addition, to avoid fluid contamination biological, or exposure of people participating in the fluid processing operation, the operations of transfer are preferably performed within a system of sealed flow, possibly pressurized, preferably formed of flexible plastic or similar material that can be discarded later of each use.

As illustrated in Figures 36 and 37, the 100A outer housing is substantially tapered with one end upper housing 110A, an outer housing wall 120A and a lower housing end 190A. The outer accommodation 100A can be made of plastic (such as the plastic listed previously), or any other suitable material. The end of upper housing 110A has an outer surface 110B, 110C interior surface and 700A housing outlet that provides a passage between said surfaces. Preferably the Upper housing will also have a 115A neck formed around of accommodation outlet 700A. The 700A accommodation outlet and The 115A neck are sized to allow the 830A body of the connection sleeve 500A pass through retaining it 790A sleeve flange, which extends from the body 830A of connection sleeve 500A. In an embodiment of the present invention an o-ring 791A can be inserted between the 790A sleeve flange and 110C inner surface of 110A end housing to ensure a tight seal fluids In an alternative embodiment of the present invention illustrated in figure 53, a second sleeve flange 790B is extends from the body 830A of the distal connection sleeve 500B to sleeve flange 790A. Both sleeve tabs 790A and 790B are adapted to fit inside neck 115A and retain the O-ring 791A in between. In this embodiment a fluid tight seal by the joint contact body O-ring 830A and inner surface 110C of the end housing 110A adjacent to neck 115A. However, the connection sleeve 500A can be fixed to container 10A by any means suitable, including for example, a lip, groove, or fit tight and adhesive with a container component 10A. The wall of outer housing joins the upper housing end 110A and the lower housing end 190A. The accommodation end Lower 190A is attached to a 180A diameter housing floor larger than the upper end 110A. The accommodation floor 180A is adapted to couple with the housing end bottom 190A and make a fluid tight seal with it. Be you can use any conventional means to fix the end from lower housing 190A to accommodation floor 180A, including, but not limited to, adhesives, ultrasonic welding or RF welding. The accommodation floor 180A may have a indentation 185A used to collect denser fluid 810. The outer housing diameter 100A increases from the end from upper housing 110A to lower housing end 190A

The outer housing 100A is adapted for connect rotationally with a rotational device 900 (figure 35), such as, for example, a rotor drive system or a turning bracket 910. The rotary connection can be, by example, a support that allows free rotation of the container 10A. The outer housing 100A preferably has a locking mechanism The locking mechanism can be one or more 150A projections designed to interact with indentations corresponding in a centrifugal tank or any other suitable interconnection or blocking mechanism or known equivalent in the technique The locking mechanism may also include a key 160 (figure 51).

With reference to figure 37, the housing exterior 100A and base 180A define an internal volume 710A in the that cores 200A and 201A will fit when container 10A is mounted. When fully assembled, cores 200A and 201A are completely within the interior volume 710A of the 100A outer housing, occupying a coaxial volume volume 710A around axis 11A.

With reference to figures 38, 40 and 44, the upper core 200A and lower core 201A are substantially tapered and respectively have upper core ends 205A, 206A; core outer walls 210A, 211A; and extremes lower core 295A, 296A. Cores 200A, 201A occupy coaxial volumes of inner volume 710A of container 10A and form the separation volume 220A between the upper end 205A and the outer wall 210A of the upper core 200A and the wall exterior 211A and the lower end 296A of the lower core 201A and the outer housing 100A. The separation volume 220A is the 710A interior volume space that is between the cores 200A and 201A and the outer housing 100A.

As illustrated in Figures 40 and 41, the upper core 200A includes the upper core end 205A and a lower core end 295A which are joined by an outer core wall 210A. The outer core wall 210A has an outer surface 210B and an inner wall surface 210C and a bottom edge 210D. The upper core diameter 200A preferably increases from the upper core end 205A to the lower core end 295A. The upper core end 205A also includes an outer surface 205B and an inner surface 205C. In the center located around the central axis and extending perpendicularly from the upper surface 205B is the lumen connector 481A. The lumen connector 481A has an upper surface 482A and a wall surface 482B. The upper surface 482A has two passages 303B and 325D that communicate fluid through the upper core end 205A with the second container channel 410A and first container channel 420A respectively. The second container channel 410A is a conduit having a duct wall 325A extending perpendicularly from the inner surface 481C of the lumen connector
481A.

As depicted in Figures 39B, 39A and 40, the second container channel 410 has fluid communication with conduit channel 760A through conduit 321A which has a first end 321B and a second end 321C that is adapted to fit in step 325D of lumen connector 481A. In the operation, conduit channel 760A of external conduit 20A has fluid communication with container channel 410A. The first container channel 420A is a second conduit that has a wall of channel 401A that extends substantially perpendicular from the inner surface 481C of the connector lumen 481A. As depicted in Figures 39A, 39B and 40, the first container channel 420A has fluid communication with the duct channel 780A of outer duct 20A through cylinder gap 322A having a first end 322B and a second end 322C adapted to fit the upper surface 482A of the hole 303B. As illustrated in an embodiment of the present invention, the second container channel 410A is arranged inside the first container channel 420A. In one embodiment alternative of the present invention illustrated in Figure 53, the duct wall 325A may be composed of the top 325F and the bottom 325G and merge with the channel walls 401A and 402A.

The upper surface 482A also has a 483A indentation that performs fluid communications with the chamber 740A When mounted, camera 740A is defined by the recess of assembly of lumen 851A minus the volumes occupied by hollow cylinders 321A and 322A in the connection joint of the sleeve 500A connection and lumen 481A connector. The 740A camera has fluid communication with duct channel 770A and with the 220A separation volume near neck 115A through the indentation 483A. Thus, the indentation 483A forms a step for the extraction of second fluid component separated 820 through the vessel chamber 740A. On the outer surface 205B are optionally a plurality of spacers 207A extending from the outer surface and contact the inner surface 110C of the upper housing end 110A to ensure fluid communications between separation volume 220A and the step formed by the indentations 483A.

In an alternative example illustrated in Figures 53, 54 and 55, the conduits 321A and 322A may be fixed to holes 325D and 303B in the upper surface 482A of the lumen connector 481A. In addition, the indentations 483A can form a plurality of channels in the lumen connector 481A and be adapted to form the chamber 740B when connected to the connection sleeve 500A or 500B. The chamber 740B is adapted to have one or more surfaces 742A that can be coupled with the male end 853A of the connecting sleeve 500A (the male end 853A surrounds the end 861 of the outer conduit 20A). To facilitate the correct orientation of the connecting sleeve 500A to the lumen connector 481A, the shapes of the male end 853A and the chamber 740B can be non-symmetrical or, as illustrated in Figures 53, 54 and 55, a guide 855A can be provided that extends from the top surface of lumen connector 481A and is adapted to fit inside hole 857A of the sleeve flange
790A

With reference again to figures 40, the lower end of core 295A includes a top plate 299A that it has an upper surface 298A, a lower surface 297A, and a 299B edge that joins and makes direct contact with the bottom edge 210D of the outer core wall 210A. The edge 299B of the plate upper 299A is adapted to join with the lower edge 210D of the outer wall of core 210A and form with it a closure fluid tight. From the upper surface 298A of the plate upper 299A perpendicularly extends a channel wall 402A, which has an upper end 402B and a lower end 402C and surrounds hole 303A that is substantially in the center of the upper plate 299A. A number of 403A fins, attached to the outer wall surface of channel 402A and upper surface 298A, support the wall of lumen 402A. Channel wall 402A is adapted to couple with the channel wall 401A forming a closure fluid tight and providing a 400A lumen. The first container channel 420A is in fluid communication with the duct channel 780A of outer duct 20A through the duct 322A. Hole 303A performs fluid communications from lumen 400A to separation volume 220A as will be explained best. The first container channel 420A also surrounds the second container channel 410A.

With reference to Figures 43A, 43B and 44, the lower core 201A includes an upper core end 206A, an outer core wall 211A and a lower core end 296A. The outer core wall 211A that has a surface exterior 211B, an interior wall 211C and lower edge 211D. He lower core diameter 201A preferably increases from the upper end of core 206A to lower end of core 296A. The lower core 201A also has an upper surface 309A and a lower surface 309B. The upper surface 309A has a substantial indentation 186A (preferably generally circular) at the center of surface 309A of the upper core end 206A. Indentation 186A has an upper surface 186B and a inner surface 186C. The upper surface 186B of the Indentation 186A has a 324D hole that extends through the inner surface 186C. In an alternative embodiment of the present invention illustrated in figure 53, the upper surface 186B may also have a recess to the 86D adapted to receive a O-ring and form a seal being of the type of fluid around of the lower end 325B of the conduit wall 325A. From the inner surface 186C around said hole 324D is extends perpendicularly the duct wall 324A which has a distal end 324B. On the upper surface 309A that extends from indentation 186A to outer surface 211B of the wall outside core 211A there are one or more channels 305A. The surface upper 309A can be horizontal or tilted up or towards down indentation 186A. If the upper surface 309A tilts up or down the indentation 186A to the end of 206A core, those skilled in the art will be able to fit consequently the shapes of the upper plate 299A and the end upper core 295A. 305A channels can have a uniform depth across the length of channel 305A. Without However, channel 305A can be tilted down or up radially from the center. Those skilled in the art will observe that if the upper surface 309A tilts up or towards below and channel 305A has a constant depth, then the channel 305A tilts accordingly upwards or towards down.

With reference to figures 38, the surface lower 297A of upper plate 299A is in direct contact with the upper surface area 309A of the lower core 201A when fully assembled This contact forms a closure fluid tight between the two surface areas that form a hole 305B from indentation 186A to channel 305A. One second hole 305C of channel 305A is formed on the outer surface 211B of outer wall of core 211A. Hole 305B performs fluid communications from indentation 186A through channel 305A and hole 305C at separation volume 220A (figures 38 and 40). Thus, fluid 800 flows through the duct channel 780A and subsequently passes through the first container channel 420A. From the first container channel 420A, the fluid 800 passes then through channel 305A at separation volume 220A.

With reference to Figures 43A and 44, the lower end of core 296A has a lower plate 300A, which it has an upper surface 300B, a lower surface 300C and an outer edge 300D. From the lower surface 300C of the Lower plate 300 extends one or more protrusions 301A. The edge 300D exterior is adapted to join the bottom edge 211D of the outer wall of core 211A and provide a tight seal to The fluids with her. Placed above the accommodation floor 180A, the lower plate 300A is circular and curves upwards radially from its center (illustrated in figure 44). Alternatively, the bottom plate 300A can be flat. How I know depicted in figure 38, when it is above the ground of 180A housing, there is a 220C volume between the lower plate 300A and accommodation floor 180A. This 220C volume is in fluid communication with separation volume 220A. The plate 300A bottom can be made of plastic or any other material suitable. Additionally, a conduit 320A extends so substantially perpendicular from the bottom surface 300C of the bottom plate 300A. The conduit 320A has a first end 320B extending to space 220C between lower plate 300A and the accommodation floor 180A, and a second end 320C that is extends above the upper surface 300B of the lower plate 300A The duct diameter 320A is adapted to fit tightly with the duct end wall 324B. The volume of the inner walls of duct 324A and 325A includes a lumen 400B The volume defined by the bottom plate 300A, surface interior 211C and roof 253A of lower core 201A, excluding the second container channel 410A, may include air or a solid material (see Figures 43B and 44).

Alternatively, as illustrated in the figure 53, there may optionally be support walls 405A and 407A. The support wall 405A extends perpendicularly from the lower surface 309B. The support wall 407A extends perpendicularly from the top surface 300B of the plate bottom 300A and connects to the support wall 405A when the lower core 201A is mounted. The duct wall 324A can be connected to conduit 320A to form a tight seal to the fluids, and ducts 324A, 320A can be melted respectively with support walls 405A and 407A. Also, from the lower surface 3000 of lower plate 300A extend one or more 409A orientation spacers that engage within the Indentation 185A.

As will be readily apparent to experts in technique, container 10A will have to be balanced around the central axis 11A. Consequently, they can be added ballasts as part of the device when appropriate facilitate the balance of the container 10A such as the ballast 408A illustrated in figure 53.

With reference to Figure 38, the container 10A is adapted so that the outer housing 100A, the cores 200A and 201A, the lower plate 300A and the upper plate 299A, the accommodation floor 180A, external ducts 20A and sleeve of connection 500A, and lumens 400A and 400B are in connection and turn together. Accommodation floor 180A of accommodation 100A exterior includes 181A recesses on its upper surface and these recesses are shaped to fit the projection 301A of the bottom plate 300A. As depicted, the bottom plate 300A It has a 301A round projection on its lower surface 300C for restrict the movement of the lower plate 300A with respect to the accommodation floor 180A. When mounted, each unique projection 301A on the lower surface of the lower plate 300A forms a Tight fit with recess 181A on housing floor 180A. Thus, when the outer housing 100A is rotated, the conduit external 20A and connection sleeve 500A, the upper core 200A, upper plate 299A, lower core 201A, plate lower 300A, accommodation floor 180A, and lumens 400A and 400B will turn with him.

As illustrated in Figure 38, lumen 400A allows whole blood 800 to reach container 10A through a first container channel 420A. The first container channel 420A provides a passage for 800 fluid inlet through lumen 400A at indentation 186A and subsequently at separation volume 220A through channel 305A. Lumen 400A is located within the upper core 200A. The lumen 400A has a height from the upper lumen end 480A and lower lumen end 402C. The lumen 400A is formed by the channel wall connection 401A extending from the inner surface 481C of the connector of lumen 481A and channel wall 402A extending from the upper surface 298A of upper plate 299A. The wall of channel 401A is supported by a plurality of fins 251A that are attached to the surface of the inner wall 210C of the wall outer core 210A and inner surface 205C of the end upper core 205A, and channel wall 402A is supported by a plurality of fins 403A (figure 40). It can be seen easily that the height of lumen 400A can be adjusted by changing the sizes and the core shapes 200A, the channel wall 401A, the wall of channel 402A, duct wall 325A, and wall height of 324A duct.

As illustrated in Figure 38, the lumen 400A, from the upper lumen end 480A to the lower lumen end 402C, encloses an inner lumen 400B. The lower lumen end 402C has a hole 303A that is in fluid communication with the separation volume 220A through several channels 305A. In the illustrated embodiment, lumen 400A includes a first container channel 420A. A second container channel 410A is located within the first container channel 420A of the upper core 200A and is enclosed therein from the end of lumen 480A and to lumen 402C. In addition, the second container channel 410A forms a passage through the lumen 400B from below the lower plate 300A for the extraction of a first separate fluid component 810 which is collected in the indentation 185A of the housing floor 180A. The second container channel 410A extends from the housing floor 180A of the outer housing 100A through lumen 400B and to the conduit channel 760A of the external conduit
20 A.

With reference to figure 38 (represented without conduit 321C), the inner lumen 400B allows blood cells to exit reds 810 of the container 10A through a second container channel 410A that provides fluid communication from the ground of housing above indentation 185A to hole 324E. Lumen inside 400B has a top end of duct 325C and a lower end of duct 324B and includes two duct walls 324A and 325A that are tightly connected to fluids and they form the second container channel 410A which has a diameter smaller and separated and is different from the first channel of 420A container The duct wall 325A is supported by a fin 251A that extends through channel wall 401A and is joins duct wall 325A. Unlike lumen 400A that has an end near indentation 186A, lumen 400B is extends beyond the indentation 186A and across the plate lower 300A. The first duct wall 325A has one end upper 325C that has a 325D hole in the upper surface 482A of the lumen connector 481A and a lower end 325B which has a 325E hole adapted to fit tightly with the end upper 324C of duct wall 324A. The upper end 324C of the conduit wall 324A is higher than the indentation 186A and It has a 324D hole. The conduit wall 324A also has a lower end 324B and is supported by a plurality of fins 252A. The lower end 324B having a hole 325E is adapted to connect to conduit 320A that has a hole 302A located near the center of the lower plate 300A. The connection of holes 325E and 302A performs fluid communication between the lumen 400B and the space 220C between the bottom plate 300A and the floor of accommodation 180A. The 220C gap between the bottom plate 300A and the accommodation floor 180A, in turn, has communication from fluid with separation volume 220A.

The 320A conduit performs a tight fit with the lower end 324B, providing support to the second channel of container 410A. Each container channel 420A and 410A can be make any type of flexible or rigid tube (such as tubes for medicine) or another device that provides a sealed passage, possibly for pressurized or depressurized fluid flow, and which can be preferably disposable and sterilizable, that is, Simple and efficient manufacturing.

1. Drive tube

As illustrated in Figures 39A and 39B, the duct assembly 860A is attached to container 10A by the connection sleeve 500A that is attached on the first end 861A of the external conduit 20A having a first conduit channel 780A, a second duct channel 760A, and a third channel of 770A duct. Each duct channel has fluid communication with a first container channel 420A, a second channel of container 410A, and a chamber chamber 740A. Three channels of duct are equally spaced 120º and have the same diameter in the outer duct 20A (see figure 50). When fluidly connects with the outer conduit 20A and container 10A, the duct channel 780A fluidly connects with the first channel of container 420A for introducing fluid 800 through the external conduit 20A to container 10A for separation. Similarly, the second channel duct 760A fluidly connects to the second channel of container 410A for removing the first separate fluid component 810 from the container 10A to the external conduit 20A. Finally the third duct channel 770A connects to the vessel chamber 740A to remove the second separate fluid component 820 from the container 10A.

As illustrated in Figure 45, the conduit external 20A has a connection sleeve 500A at the first end 861A and an anchor sleeve 870A at the second end 862A of the external conduit 20A. Between the connection sleeve 500A and the anchor sleeve 870A in the outer conduit 20A there are optionally a first projection 882 and a second projection 884 which they extend perpendicularly from the outer conduit 20A and are of greater diameter. Between the 500A connection sleeve and the sleeve anchor 870A (or, if present, the first and second projection 882, 884) there is a first and a second support ring 871A and 872A. The outer conduit 20A, the anchor sleeve 870A and the connection sleeve can be made of the same or different biocompatible materials of adequate strength and flexibility for use in this type of tubes in a centrifuge (a material preferred is HYTREL®). The connection sleeve 500A and the sleeve 870A anchor can be attached through any means suitable such as adhesives, welding, etc; However, for facilitate manufacturing it is preferred that the connection sleeve 500A and anchor sleeve 870A are overmolded to the duct external 20A.

With reference to figures 45, 48 and 49, the 870A anchor sleeve includes an 877B body that has a first anchor end 873A and a second anchor end 874A. He anchor sleeve 870A is attached to the second conduit end 862A of the outer conduit 20A (preferably by overmolding) e increase the diameter from the first ring 873A to the ring 874A. Distally spaced from the second end 874A there is a ring 886A, which extends perpendicularly to the 877B body and of greater diameter than the 877B body of the 870A anchor sleeve. A plurality of 877A nerves that have a first 877B nerve end between the ring 886A and the second anchor end 873A and a second end of 877C nerve that extends beyond the first end of 873A anchor are attached to the 877B body. The second extremes of 877C nerve are joined together by an 880A hoop, which also It is connected to the external conduit 20A. The 877A nerves extend parallel to the outer conduit 20A and are preferably placed over the region where duct channels 760A, 770A, and 780A are closer to the surface of the outer duct 20A (figure fifty). The regions where duct channels 760A, 770A and 780A are closer to the outer diameter of the outer conduit 20A a unless they reinforce, they tend to fail during rotation to high speed. The provision of parallel nerves with the channels duct beyond the anchor sleeve end 873A provides reinforcement to this region and prevents duct failure to high speed rotation. In one aspect, the nerves prevent buckling of the external duct 20A in this region and act as structural elements to transfer the torsional effort to 870A anchor sleeve.

The 500A connection sleeve includes a body 830A having an upper end of sleeve 831A and an end lower sleeve 832A (figures 46 and 47). Cuff end Bottom 832A has a 790A sleeve flange and a plurality of 843A projections, which are sized to engage indentations 484A on the wall surface 482A of the connector lumen 481A. When the container 10A is mounted, it can be obtained a fluid tight seal by placing the o-ring 791A around the 830A body and compressing the 791A O-ring between 790A tab and 100A housing. The upper end of sleeve 831A is adapted to be attached to the outer conduit 20A. With reference to figures 46, 39A and 39B, the connecting sleeve 500A is fixed to container 10A by means of the sleeve flange 790A and is adapted to fluidly connect the channels of conduit 780A, 760A, 770A from external conduit 20A to the channels of container 420A and 410A, and chamber 740A of container 10A. When is mounted, the 500A connection sleeve is mounted on the connector of lumen 481A (Figures 39A and 39B).

500A connection sleeve increases preferably in diameter from the upper end of the sleeve 831A to the lower end of sleeve 832A and is overmolded to the first duct end 861A of the outer duct 20A. He connection sleeve 500A connects the container 10A to the conduit external 20A without using a rotary seal, so otherwise it would normally be placed between the container 10A and the sleeve 500A connection. The connection is not sealed between the container 10A and the connection sleeve 500A can be produced, as has been explained above, alternatively by use, by example of an o-ring, a groove, or lip, connection of the type of rubber washer, welding, or a tight fit with or without adhesive in container 10A or connection sleeve 500A.

As illustrated in Figures 46 and 39B, the 790A sleeve flange has an 847A bottom surface that contact top surface 482A of lumen connector 481A forming a tight seal. However, the lumen connector 481A has a plurality of 483A indentations that perform fluid communication between the separation chamber 220A and the container chamber 740A, which, in turn, has communication of fluid with duct channel 770A. 740A vessel chamber It is defined by the lumen mounting recess 851A and the surface upper 482A of lumen connector 481A, excluding space occupied by the hollow cylinders 321A and 322A. A plurality of protrusions 843A on the bottom surface 847A of the tab 790A sleeve hook and slide to 484A indentations in the 482B wall surface of lumen connector 481A, thus performing a tight fit.

The 500A connection sleeve helps fix the external conduit 20A to container 10A, thus connecting by fluid the outer conduit 20A to the container 10A. This fluid connection allows fluid 800 to be supplied through the external conduit 20A to the container 10A. Likewise, this fluid connection also allows remove separate fluid components 820 from container 10A a through external conduit 20A.

The outer conduit 20A has a diameter approximately constant that helps reduce stiffness. A excessively rigid external conduit 20A will heat up and fail more quickly In addition, a constant diameter conduit is cheap / easy to manufacture, allows easy experimentation with 500A connection sleeve and anchor sleeve sizes 870A, and allows you to easily slide support rings 871A, 872A over. The movement of supports 871A and 872A will be retained preferably by first and second projections 882A and 884A. He External conduit 20A can be made of any type of pipes flexible (such as medicine tubes) or other device that provide a sealed passage for fluid flow, which can be pressurized, to or from a deposit of any kind, and that It can be preferably disposable and sterilizable.

II. The permanent tower system

Figure 17 illustrates the 2000 tower system. The 2000 tower system is the permanent equipment (that is, no disposable) that receives the various devices from the kit 1000 photophoresis, such as the 1100 cassette, the camera irradiation 700, and the centrifuge vessel 10 (Figure 1). He 2000 tower system performs regulation, pumping and control general and fluid flow movement through the kit 1000 disposable photophoresis. The 2000 tower system performs automatically all necessary control functions by the use of a properly programmed controller, for example a processor or IC circuit, coupled to all necessary components. Although a new disposable kit should be discarded after each session of photophoresis therapy, the 2000 tower system is used several times. The 2000 tower system It can be modified to perform several treatments extracorporeal blood circuit, for example apheresis, by properly programming the controller or changing some of its components.

The 2000 tower system has a housing which has an upper portion 2100 and a base portion 2200. The base portion 2200 has a top 2201 and a bottom 2202. 2203 wheels have been arranged at or near the bottom 2202 of the base portion 2200 so that the 2000 tower system be mobile and can be easily moved from one room to another in a hospital. Preferably, the front wheels 2203 are pivotable around a vertical axis for easy steering and the management of the 2000 tower system. The top 2201 of the base portion 2200 has an upper surface 2204 which has a control cover 1200, better illustrated in Figure 22, built in it (see figure 22). In figure 17, the cassette 1100 has been loaded onto control cover 1200. The portion of 2200 base also has hooks (not illustrated), or other connectors, to hang a plasma collection bag 51 and a treatment bag 50. Such hooks may be located in anywhere in the 2000 tower system on condition that your position does not interfere with the operation of the system during therapy. The base portion 2200 has a photoactivation chamber 750 (figure 18) located behind door 751. They have been arranged additional hooks (not shown) in the 2000 tower system to hang saline and anticoagulant bags. These hooks are preferably placed in the upper portion 2100.

The photoactivation chamber 750 (figure 18) is arranged in the base portion 2200 of the 2000 tower system between the top 2201 and the bottom 2202 behind the door 751. Door 751 is articulated connected to the portion 2200 base and is planned to access the camera 750 photoactivation and so that the operator can close the camera 750 photoactivation so that UV light does not escape into the environment during the treatment. The recess 752 is planned so that they can pass tubes 1112, 1117 (figure 1) to the photoactivation chamber 750 when the irradiation chamber 700 is charged and when the door 751 is closed. The photoactivation camera is explained with detail below with respect to figures 16 and 18.

The upper portion 2100 is located above the base portion 2200. The centrifugal chamber 2101 (figure 19) is located in the upper portion 2100 behind door 2102 of the centrifugal chamber Door 2102 of the centrifugal chamber has a window 2103 so that the operator can see the centrifugal chamber 2101 and monitor problems. The 2103 window is made of glass thick enough to withstand the forces that can be exercise in case of accident during centrifugation which can rotate the centrifuge vessel at speeds greater than 4800 RPMs Preferably, window 2103 is made of glass proof hits. Door 2102 is articulated connected to the 2100 upper portion and has an automatic locking mechanism which is activated by the system controller during operation of the system. Centrifugal chamber 2101 is explained below. in more detail with respect to figure 19.

The cover 1200 is preferably placed on the upper surface 2204 of the base portion 2200 at or near the front of the tower system 2000 while the upper portion 2100 extends upward from the base portion 2200 near the rear of the tower system 2000. This allows the operator easy access to the control cover 1200 while simultaneously providing access to the centrifuge chamber 2101. Designing the tower system 2000 so that it has the centrifuge chamber 2101 in the upper portion 2100 and the photoactivation chamber 750 and the cover 1200 in the base portion 2200, a vertical configuration is achieved. As such, the 2000 tower system has a size that occupies little space and occupies a reduced space on the valuable floor of the hospital. The height of the 2000 tower system remains below sixty inches so that the view is not obstructed when transporting the machine through the hospital from behind. Additionally, the provision of the cover 1200 in a fairly horizontal position provides the operator with a position to place the photophoresis kit 1000 devices while loading other devices, facilitating loading. The 2000 tower system is robust enough to resist forces and vibrations produced by the process of
centrifugation

A monitor 2104 has been arranged at the door 2102 of the centrifugal chamber above the window 2103. The monitor 2104 has a display area 2105 to present visually operator data, such as user interfaces for data entry, loading instructions, graphics, warnings, alerts, therapy data, or therapy progress. The monitor 2104 is coupled and is controlled by the system controller. A  data card reception port 2001 is arranged in a monitor side 2104. The data card receiving port 2001 is planned to receive the data card slider 1195 supplied with each 1000 disposable photophoresis kit (Figure 1). As mentioned above, the card 1195 data may be preprogrammed to store multiple data at supply the 2000 tower system controller. For example, the 1195 data card may be programmed to transmit information so that the system controller can ensure: (1) that the disposable photophoresis kit is compatible with the blood movement equipment in which it is loaded; (2) that the kit photophoresis is able to carry out the treatment process wanted; (3) that the disposable photophoresis kit be of a certain Brand or manufacturing. The data card receiving port 2001 has the necessary hardware and circuitry to read and write data to data card 1195. Preferably, the data card receiving port 2201 will record data from the treatment therapy on data card 1195. Such information may include for example, hours of collection, volumes of collection, treatment times, volumetric flow rates, alarms, malfunction, disturbances in the process, or any other desired data. Although the reception port of 2001 data card is arranged on monitor 2104, it may be located anywhere in the 2000 tower system on condition that is coupled to the system controller or other means appropriate control.

A. Photoactivation camera to receive the camera from irradiation

With reference now to figures 16 and 18, the 750 photoactivation chamber is illustrated in cross section. The 750 photoactivation chamber is formed by housing 756. The housing 756 fits within the base portion 2200 of the 2000 tower system behind door 751 (figure 17). The camera of photoactivation 750 has a plurality of connection holes electrical 753 arranged on the rear wall 754. The holes of electrical connection 753 are electrically coupled to a source electric power The 750 photoactivation camera is designed to receive the UVA 759 light assembly (figure 16). When they are fully loaded in the 750 photoactivation chamber, the electrical contacts (not shown) located on the contact wall  755 of the UVA 759 light assembly form an electrical connection with electrical connection holes 753. This electrical connection allows to supply electricity to the UVA 758 lamps so that can be activated. Preferably, three are planned electrical connection holes for each set of UVA lamps 758. More preferably, the UVA 759 light assembly has two sets of 758 UVA lamps forming a space in which you can enter the irradiation chamber 700. The supply of Electric power to lamps UVA 758 is controlled by the properly programmed system controller using a switch. UVA 758 lamps are activated and deactivated when necessary by the controller during the therapy session  of photophoresis

The ventilation hole 757 is arranged in the upper part of the housing 756 near the rear wall 754 of the photoactivation chamber 750. Vent hole 757 connects with ventilation duct 760 coming out of the part rear of the 2000 tower system. When the heat generated by the UVA 758 lamps accumulates in the 750 photoactivation chamber during a treatment therapy, this heat escapes from the chamber of photoactivation 750 by the vent hole 757 and the 760 ventilation duct. Heat leaves the tower system 2000 through the 761 tower housing hole located in the rear of the 2000 tower system, away from the patient and the operator.

The 750 photoactivation camera also includes the tract 762 to receive the irradiation chamber 700 and maintain irradiation in an upright position between UVA 758 lamps. Tract 762 is at or near the bottom of the chamber of 750 photoactivation. Preferably, a circuit of leak detector 763 under tract 762 to detect leaks of irradiation chamber fluid 700 during, before or after of the operation. The leak detector circuit 762 has two U-shaped electrodes located in a circuit Flexible reinforced with adhesive. The electrodes are designed to  allow the application of a short circuit to test if there is discontinuities One end of each electrode goes to a circuit integrated while the other end of each electrode is attached to a solid state switch. Solid state switch It can be used to check the continuity of the electrodes. By closing the switch, the electrodes short circuit each other. other. The integrated circuit then detects the short. The closure of the switch produces a situation equivalent to humidification of the electrodes (i.e. an escape). If the electrodes are damaged in any way, the continuity test will fail. This is A positive indication that the electrodes are not damaged. This test can be performed every time the system is booted. or periodically during normal operation to ensure that the 762 leak detection circuit works properly. He 762 leak detection circuit helps ensure leaks do not go unnoticed during a full therapy session because the leak detection circuit is damaged. A scheme Electrical leak detector circuit 762 is offered in the figure 20.

B. Centrifugal chamber

Figure 19 illustrates centrifugal chamber 2101 in cross section with the 2000 tower system housing taken away. The rotational device 900 (also in section transverse) capable of using spin technology 1-omega 2-omega is placed inside the centrifuge chamber 2101. The rotational device 900 includes a 910 rotary stand and a 919 container holding plate for rotatably fix the centrifuge container 10 (figure 1). He 2107 housing of centrifugal chamber 2101 is made preferably of aluminum or some other light and resistant metal. Alternatively, other rotational systems can be used within of the tower system 2000 as described in the Patent of United States number 3,986,442.

The leak detection circuit 2106 is arranged in the rear wall 2108 of the housing 2107. The circuit  2106 leak detection is planned to detect leaks inside the centrifuge container 10 or the connection tubes during processing. The leak detection circuit 2106 is identical to the leak detector circuit 762 described previously. An electrical scheme of the detection circuit of Leakage 2106 is set forth in Figure 21.

C. Fluid flow control cover

Figure 22 illustrates control cover 1200 of the 2000 tower system (figure 17) without a loaded 1100 cassette over. The control cover 1200 performs the regulation and the pumping in order to drive and control the flow of fluid in every photophoresis kit 1000. Preferably, the cover 1200 is a separate plate 1202 that is fixed to the base portion 2200 of the 2000 tower system using screws or other means of fixing, such as, for example, bolts, nuts, or clamps. Plate 1202 can be made of steel, aluminum, or other metal or durable material.

The 1200 deck has five pumps peristaltic, whole blood pump 1301, return pump 1302, recirculation pump 1303, anticoagulant pump 1304, and the 1305 red blood cell pump that extend through of plate 1202. Pumps 1301-1305 are arranged on plate 1202 so that when cassette 1100 is loaded on deck 1200 for operation, the loop tubes of 1120-1124 pump spread over and around the 1301-1305 pumps (figure 25).

A set of air bubble sensor 1204 and HCT sensor assembly 1205 are arranged on plate 1202. The air bubble sensor set 1204 has three trenches 1206 for receive tubes 1114, 1106, and 1119 (figure 25). Set 1204 air bubble sensor uses ultrasonic energy to monitor in tubes 1114, 1106, and 1119 density differences that would indicate the presence of air in the liquid fluids that They normally pass through. The tubes 1114, 1106, and 1119 are supervised because these lines go to the patient. Set air bubble sensor 1204 is operatively coupled and transmits data to the system controller for analysis. Whether detects an air bubble, the system controller will interrupt the operation and will prevent the flow of fluid to the patient by closing the 1114, 1106, and 1109 tubes moving compression actuators 1240-1242 to a raised position, compressing by it tubes 1114, 1106, and 1119 against cassette 1100, as has been explained above and / or turning off the appropriate pump. Set HCT sensor 1205 has a ditch 1207 to receive the HCT component 1125 of tube 1116. The HCT sensor assembly 1205 monitors in the 1116 tube the presence of red blood cells using a sensor photoelectric. The HCT 1205 sensor assembly is also coupled Operationally and transmits data to the system controller. He sensor assembly HCT 1205 detects the presence of red blood cells in the 1116 tube, the system controller will carry out the action appropriate, such as stopping the appropriate pump or activating one of the 1243-1247 compression actuators, to stop the fluid flow through tube 1116.

The 1200 deck also has five compression actuators 1243-1247 and three 1240-1242 compression actuators strategically placed on plate 1202 so that when the Cassette 1100 is loaded on deck 1200 for operation, each 1240-1247 compression actuator is aligned with corresponding holes 1137 and 1157. The actuators of 1240-1247 compression can be moved between a position lowered and one position raised. As illustrated in the figure 22, the compression actuators 1243-1247 are in the lowered position and compression actuators 1240-1242 are in the raised position. When they are in a raised position, and when the cassette 1100 is loaded in the cover 1200 as illustrated in figure 25, the actuators of 1240-1247 compression will extend through the corresponding holes 1137 or 1157 and will compress the portion of flexible tubes aligned with said hole, thereby closing by Compress the flexible tube so that fluid cannot pass. When they are in the lowered position, the compression actuators 1240-1247 do not extend through the holes 1137 and 1157 and thus do not compress the flexible tubes.

Compression actuators 1243-1247 are removed by spring so that their default position moves to the lowered position unless be activated 1243-1247 compression actuators are independently controlled and can be raised or lowered independently of each other. Moreover, the actuators of 1240-1242 compression are coupled together. As such, when a compression actuator 1240-1242 is down or up, the other two 1240-1242 compression actuators also They go down and up accordingly. Additionally, the actuators 1240-1242 compression are pushed by spring so that its default position moves to the raised position. Thus, if the system loses power during a therapy session, 1240-1242 compression actuators will pass automatically to the raised position, the tubes 1114, 1106 will close, and 1119 and will prevent fluid from entering or leaving the patient.

With reference now to figures 23 and 24, the cover 1200 also includes the 1210 system controller, the cylinder set 1211, manifold assemblies 1213, cable pump 1215, pump motor cable 1216, and belt assembly 1217 timer. The 1210 system controller is a circuit properly programmed integrated that is operatively coupled to the necessary system components to perform all the functions, interactions, decisions, and reaction explained previously and necessary to perform a photophoresis therapy according to the present invention. Cylinder assembly 1211 couples each compression actuator 1240-1247 at a pneumatic cylinder. Air holes 1212 are arranged in the various elements of the cover 1200, as necessary, to connect air lines to the devices and the appropriate manifold of manifolds 1213. As such, air can be supplied to the devices as needed to move the component necessary, such as compression valves 1240-1247. All these functions and timing are controlled by system controller 1210. The set of Timer belt 1217 is used to coordinate the rotation of rotary clamps 1203. Finally, plate 1202 includes a plurality of holes 1215, 1219, 1220, 1221, and 1218 so that the various components of the cover 1200 can be loaded properly therein and so that the cover 1200 can be fixed to the 2000 tower system. Specifically, the pumps 1301-1305 fit holes 1314, the set HCT sensor 1205 fits in hole 1220, the detector assembly of air bubbles 1204 fits into hole 1219, the actuators of 1240-1247 compression extend through the holes 1218, and the bolts extend through the holes 1221 to fix the cover 1200 to the 2000 tower assembly.

1. Cassette fixing mechanism

With reference now to Figures 22 and 25, the method by which the cassette 1100 is loaded and fixed to the cover 1200 will be explained below. In order for the 2000 system to carry out a photophoresis therapy, the cassette 1100 must be properly loaded on the cover 1200. Because of the compression actuator regulation system incorporated in the present invention, it is imperative that the cassette 1100 is properly fixed to the cover 1200 and does not move or dislodge when the compression actuators 1240-1247 close portions of the hoses by compressing the hoses against the cover 1130 of the cassette 1100 (figure 3). However, this requirement competes with the desired purposes of ease of loading the cassette 1100 on the cover 1200 and reducing operator errors. All these objectives are achieved with the cassette fixing mechanism described more
ahead.

In order to facilitate the fixing of the cassette 1100 to cover 1200, cover 1200 is provided with two seals 1208 and two rotary clamps 1203 and 1223. The seals 1208 have a slot 1228 near the middle of the top plate. The seals 1208 are fixed to the plate 1202 in positions predetermined so that the spacing between them is substantially identical to the spacing between tabs 1102 and 1103 in cassette 1100 (figure 2). 1203 rotary clamps and 1223 are illustrated in a closed position. However, the 1203 and 1223 rotary clamps can be rotated to a position open (not illustrated) manually or by actuation Automatic pneumatic cylinder. 1203 rotary clamps and 1223 are pushed by spring by torque springs so that automatically return to the closed position when not applied additional torque Rotating clamps 1203 and 1223 are linked together by the 1217 timing belt assembly (figure 24).

With reference now to figure 23, the set Timer belt 1217 includes the 1226 timer belt, 1224 pair spring housings, and 1225 tensioner assembly. 1217 timing belt assembly coordinates the rotation of the rotary clamps 1203 and 1223 so that if one turns, the other Also turn in the same direction and the same amount. In others terms, rotary clamps 1203 and 1223 are coupled. He tensioner set 1217 ensures that the 1226 timing belt has sufficient tension to engage and rotate the rotary clamp 1203 or 1223 that is being coordinated. The spring lodgings of torque 1224 provide housing for torque springs that move rotary clamps 1203 and 1223 to position closed.

With reference again to figures 22 and 25, when loading the cassette 1100 on the cover 1200, the cassette 1100 is angles cover 1200 and tabs 1102 and 1103 at an angle (figure 2) line up with seals 1208. Cassette 1100 is moved so that tabs 1102 and 1103 are inserted slidingly on seals 1208. Rotating clamps 1203 and 1223 are then in the closed position. The back of the  cassette 1100 (that is, the opposite side to tabs 1102 and 1103) contact rotary clamps 1203 and 1223 when the tabs 1102 and 1103 are inserted into seals 1108. When applied force down to cassette 1100, rotary clamps 1103 and 1123 will rotate to the open position, allowing the part Rear of cassette 1100 moves down to a position under projections 1231 of rotary clamps 1203 and 1223. Once the 1100 cassette is in this position, the 1203 and 1223 rotary clamps jump again by force applied by the torque springs and return to the closed position, blocking cassette 1100 in position. When in position locked, cassette 1100 can resist forces up and lateral.

To remove cassette 1110 after finishing the therapy session, rotary clamps 1203 and 1223 are turn to the open position manually or automatically. Rotation automatic is provided by a pneumatic cylinder that is coupled to an air line and the 1210 system controller. Once the rotary clamps 1203 and 1223 are in the open position, the cassette 1100 is removed by simply raising and sliding the tabs 1102 and 1103 removing them from seals 1208.

2. Automatic loading peristaltic pumps

With reference to figure 24, the pumps peristaltic 1301-1305 are arranged in the cover 1200 and are used to move fluids through kit 1000 photophoresis (figure 1) along desired paths. The activation, deactivation, timing, speed, coordination, and all other functions of peristaltic pumps 1301-1305 are controlled by the controller 1210 system. Peristaltic pumps 1301-1305 They are identical in structure. However, the placement of each pump peristaltic 1301-1305 on deck 1200 dictates the function of each peristaltic pump 1301-1305 with regarding what fluid is moving and along what travel. This is because the placement of peristaltic pumps 1301-1305 dictates which pump loop 1220-1224 will be loaded into them.

With reference now to Figures 28 and 29, the whole blood pump 1301 is illustrated in detail. The structure and operation of the whole blood pump will be well understood that peristaltic pumps 1302-1305 are identical. The whole blood pump 1301 has a motor 1310, a position sensor 1311, a pneumatic cylinder 1312, a pneumatic actuator 1313, a rotor 1314 (better illustrated in Figure 30), and a housing
1315

The rotor 1314 is rotatably mounted inside the housing 1315 and is in operable connection with the drive shaft 1316 of the motor 1310. Specifically, the rotor 1314 is mounted within the curved wall 1317 of the housing 1315 so that it can be rotated with the motor 1310 around the AA axis. When the rotor 1314 is mounted in the housing 1315, there is a space 1318 between the rotor 1314 and the curved wall 1317. This space 1318 is the tube pumping region of the whole blood pump 1301 in which the loop tube of Pump 1121 (Figure 33) fits when charging for pumping. The position sensor 1316 is coupled to the drive shaft 1316 of the engine 1310 so that the rotational position of the rotor 1314 can be monitored by monitoring the drive shaft 1316. The position sensor 1311 is operatively connected and transmits data to the system controller 1210 (figure 24). Analyzing this data, the system controller 1210, which is also coupled to the motor 1310, can activate the motor 1310 to place the rotor 1314 in any rotational position
desired.

Housing 1315 also includes a tab 1319. The hosting tab 1319 is used to fix the whole blood pump 1310 to the cover plate 1202 1200 (figure 22). More specifically, a bolt extends to through bolt holes 1320 of housing flange 1319 to thread holes inside plate 1202. The tab Housing 1319 also includes a hole (not shown) so that the pneumatic actuator 1313 can extend therethrough. This hole is sized so that the pneumatic actuator 1313 can be moved between an up and down position without considerable resistance The pneumatic actuator 1313 is activated and deactivated by the pneumatic cylinder 1312 as a piston through the use of air. The pneumatic cylinder 1312 includes an air inlet hole 1321 to connect an air line of supply. When air is supplied to the pneumatic cylinder 1312, the pneumatic actuator extends upward through the 1319 housing tab to a raised position. When interrupts the air supply to the pneumatic cylinder 1312, the pneumatic actuator retracts to pneumatic cylinder 1312, returning to the lowered position. The 1210 system controller (figure 22) controls the air supply to the inlet hole of air 1321.

The curved wall 1317 of the housing 1315 It contains two 1322 slots (only one is visible). Slots 1322 are located on substantially opposite sides of the wall curved 1317. Slots 1322 are intended for the tube to pump loop 1121 (figure 33) can pass to the pumping region of tube 1318. More specifically, the pump inlet portion 1150 and the outlet portions 1151 (figure 33) of the loop tube of Pump 1121 pass through slots 1322.

Turning now to figures 30 and 31, the rotor 1314 is illustrated removed from housing 1315 so that its components are more clearly visible. The 1314 rotor has a upper surface 1323, inclined guide 1324, rotor flange 1325, two guide rollers 1326, two drive rollers 1327, and rotor floor 1328. Guide rollers 1326 and rollers drive 1327 are rotatably fixed around cores 1330 between the rotor floor 1328 and a lower surface 1329 of the rotor flange 1325. As best illustrated in Figure 29, the cores 1330 fit into holes 1331 of the rotor floor 1328 and the recesses 1332 on the lower surface 1329. The rollers of guide 1326 and drive rollers 1327 fit around the 1330 cores and can rotate around them. They are arranged preferably two guide rollers 1326 and two rollers of drive 1327. More preferably, guide rollers 1326 and the drive rollers 1327 are arranged in the rotor 1314 so that they are in an alternate configuration.

With reference to figures 29 and 31, the 1327 drive rollers are intended to compress the portion of pump loop tube 1121 that is loaded in the region of pumping tube 1318 against the inner curved wall 1317 when the rotor 1314 rotates around the A-A axis, deforming therefore the tube and causing fluids to flow through the tube. The rotational speed change of rotor 1314 will change correspondingly the flow rate of fluid through the tube. Guide rollers 1326 are intended to maintain the portion of pump loop tube 1121 that is loaded in the pumping region of tube 1318 properly aligned during pumping. Additionally, guide rollers 1326 help to load suitably the pump tube loop 1121 in the pumping region of tube 1318. Although guide rollers 1326 are illustrated with uniform cross section, it is preferred that the top plate of the guide rollers are tapered so that it has one more edge sharpened near its outer diameter. The taper of the plate upper results in a guide roller with a sectional profile non-symmetric cross Tapered realization helps ensure proper loading of the tubes in the tube pumping region.

The rotor 1314 further includes a cavity 1328 It extends through its center. Cavity 1328 is designed to connect rotor 1314 to drive shaft 1316 of the 1310 engine.

With reference now to figures 30 and 32, the rotor flange has a hole 1333. The hole 1333 is defined by a leading edge 1334 and a trailing edge 1335. The terms front and output are used assuming rotor rotation 1314 in the right direction is the direction towards forward while rotating the 1314 rotor in one direction To the left is the backward direction. However, the invention is not limited to it and can be modified for pumps towards the left. The leading edge 1334 is beveled down to the hole 1333. The trailing edge 1335 extends upward from the upper surface of the rotor flange 1325 higher than the leading edge 1334. The leading edge is intended for the trailing edge capture and feed pump loop tube 1121 to the pumping region of tube 1318 on rotor 1314 when turning in the forward direction.

The 1314 rotor also has an inclined guide 1324 extending upward, at an inverted angle, from the rotor flange 1325. The inclined guide 1324 is intended for move the pump loop tube 1121 towards the rotor flange 1325 when rotating rotor 1314 in the forward direction. Preferably, the inclined guide 1324 has a raised edge 1336 extending along the upper surface 1323 to manual hitch by the operator, if necessary. Plus preferably, the inclined guide 1314 is located forward of the leading edge 1334.

With reference now to figures 28 and 33, the 1301 whole blood pump can load and unload automatically  the pump loop tube 1121 a and the tube pumping region 1318. Using position sensor 1311, rotor 1314 is rotated to a loading position where the inclined guide 1324 will look at the 1100 cassette when the 1100 cassette is loaded on the cover 1200 (figure 25). More specifically, the 1314 rotor is located in a position so that the inclined guide 1324 is located between the input portion 1150 and the output portion 1151 of the pump loop 1121 when cassette 1100 is fixed to the cover, as illustrated in figure 13. When the cassette 1100 is fixed to the cover 1200, the pump loop tube 1121 extends on and around the rotor 1314. The pneumatic actuator 1313 is then in the lowered position.

Once the 1100 cassette is properly fixed and the system is ready, rotor 1314 is turned on the direction to the right (that is, the direction forward). When the rotor 1314 rotates, the pump tube loop 1121 is contacted by the inclined guide 1324 and moves against the upper surface of rotor flange 1325. Portions of pump loop tube 1121 that are displaced against the flange of rotor 1325, are then contacted by the trailing edge 1325 and fed down to the tube pumping region 1318 to through hole 1333. A guide roller 1326 has been arranged directly after hole 1333 to place more properly the tubes inside the tube pumping chamber to pumping by drive rollers 1327. When loaded, the inlet portion 1150 and the outlet portion 1151 of the tube of pump loop 1121 pass through grooves 1322 of the wall curved 1317. It takes a revolution and a half to load completely the tubes.

To automatically download the tube loop of pump 1121 of the whole blood pump 1301 after end the therapy, the rotor 1314 is rotated to a position where the hole 1333 is aligned with slot 1322 through which passes the output portion 1151. Once aligned, the pneumatic actuator 1313 is activated and extends to the position rising, contacting and raising the output portion 1151 to a height above the trailing edge 1335. The rotor 1314 is rotated then in the direction to the left, making the edge output to 1335 contact and remove pump loop tube 1121 from the tube pumping region 1318 through the hole 1333.

D. Infrared communication

With reference to figure 34, the system of tower 2000 (figure 17) also preferably includes an interface  Wireless infrared communication ("IR") (no represented). The wireless IR interface consists of three elements primary, the 1210 system controller, the integrated circuit of IRDA protocol, 1381, and IRDA transceiver port 1382. The IR communication interface is capable of transmitting and receiving data by IR signals from a remote computer or other device that have IR capabilities When sending data, the system controller 1210 sends serial communications data to the IRDA protocol chip 1381 to put the data in buffer. Chip IRDA 1381 protocol adds additional data and other information from communication to the transmission chain and then send them to IRDA transceiver 1382. Transceiver 1382 converts data electrical transmission to coded light pulses and the transmits to a remote device through a phototransmitter.

When receiving data, the IR data pulses are received by a photodetector located on the 1382 transceiver chip. The 1382 transceiver chip converts optical pulses into data electrical and sends the data stream to IRDA protocol chip 1381 where the electrical signal is devoid of control and content Additional IRDA protocol. The remaining data is sent subsequently to system controller 1210 where the current of Data is analyzed according to the communications protocol.

Incorporating an IR communication interface in the 2000 tower system, real-time data relating to a therapy session can be transmitted to a remote device for registration, analysis, or additional transmission. The data can be sent by IR signals to the 2000 tower system to control therapy or be able to change protocols in a state blind. Additionally, IR signals do not interfere with another hospital equipment, like other wireless transmission methods, as radio frequency

III. Photophoresis treatment process

With joint reference to Figure 26, a flowchart that includes layer photoactivation leukocyte, and figure 27, a schematic representation of apparatus that can be used in such an embodiment, the process begins 1400 with a patient 600 connected by means of an adapter 1193 needle that supports a needle, for blood collection, and a 1194 needle adapter that supports another needle, to return blood Treated and other fragments. Saline bag 55 is connected by connector 1190 and anticoagulant bag 54 is connected through connector 1191. Actuators 1240, 1241, and 1242 open, the anticoagulant pump 1304 rotates, and the saline actuator 1246 opens so that the entire set of disposable tubes is cebe 1401 with saline 55 and anticoagulant 54. Centrifuge 10 rotates in 1402, and 1403 mixture is pumped from blood-anticoagulant to the centrifuge container 10, with pump A / C 1304 and pump WB 1301 controlled at a 1:10 speed ratio.

When the volume collected reaches 150 ml 1404, the return pump 1302 is set 1405 at the pump speed of collection 1301 until 1406 red blood cells are detected in a sensor HCT (not shown) in centrifugal chamber 1201 (Figure 19). Packaged red blood cells and leukocyte layer have accumulated in this point in the centrifuge container and are ejected slowly at a rate, controlled by the processor, which maintains the red blood cell line at the level of the sensor interface.

The 1305 red blood cell pump is then placed 1407 to 35% of the input pump speed, controlling 1408 at the same time the rate to keep the cell line level interface until 1409 the volume of the cycle is reached collection, point at which the 1305 red blood cell pump is turned off 1410 and the fluid path to the treatment bag 50 by the HCT sensor 1125 opens by lowering the actuator 1244, and stops when the HCT 1125 sensor detects red blood cells 1411. The "volume collection cycle "is defined as processed whole blood desired divided by the number of collection cycles, for example a  1500ml desired blood process target may require 6 cycles, and thus 1500/6 is a volume of 250 ml. Continuing in 1410 the patient's whole blood supply to the recipient and with the red blood cell pump off, red blood cells will accumulate and they will expel the leukocyte layer inside the container 10. The red blood cells are used to expel the leukocyte layer and will be detected by the effluent hematocrit sensor (HCT), indicating that the leukocyte layer has been collected.

If another 1412 cycle is needed, the path of Centrifugal effluent 10 is returned 1413 to the plasma bag 51 and the red blood cell pump rate 1305 is increased by 1413 to the pumping rate of the inlet pump 1301 until the red blood cells are detected 1414, which is the beginning of the second cycle. If another cycle 1412 is not needed, centrifuge 10 is turned off. 1415 and inlet pump 1301 and anticoagulant pump 1304 They are placed at a KVO rate, 10 ml / h in this embodiment. The tour of effluent is directed 1416 to plasma bag 51, the rate of the 1305 red blood cell pump is set 1417 at 75 ml / min, the pump recirculation 1303 and photoactivation lamps are activated 1418 for a period sufficient to treat the leukocyte layer, calculated by the controller depending on the volume and type of treated disease

When the container 10 is empty 1419, the 1305 red blood cell pump turns off 1420 and plasma bag 51 is emptied 1421 by opening the actuator 1247 and continuing the pump return 1302. Return pump 1302 turns off 1422 when the plasma bag 51 is empty and when photoactivation has finished 1423, the treated cells are returned 1424 to the patient from plate 700 by means of return pump 1302. It is used saline to wash the system and the rinse is returned to the patient, completing process 1425.

The anticoagulant, the patient's blood, and the fluid that returns to the patient are monitored by detectors air 1204 and 1202, and the fluid returns to the patient through the drip chamber and filter 1500. Pumps 1304, 1301, 1302, 1303, and 1305, the actuators 1240, 1241, 1242, 1243, 1244, 1245, 1246, and 1247, and the rotation of the container 10 are controlled by the processor programmed in the tower.

The process and related device have advantages significant on previous processes and devices because the invention allows the leukocyte layer to be longer in the container because the red blood cells are removed while collect the leukocyte layer in the container during centrifugation, keeping more leukocyte layer in the container until the desired amount of layer cells has been collected  leukocyte before removing cells from the leukocyte layer. Platelets, leukocytes, and other fractions can also be separated from the leukocyte layer, or red blood cells can be collected instead of bringing them back with the plasma to the patient as the process does illustrated.

It has been found that the increase in time that the leukocyte layer 810 undergoes rotational movement in the centrifuge container 10 produces a "cleaner cut" of leukocyte layer 820. A "cleaner cut" means that the Hematocrit count (HCT%) has decreased. HCT% is the amount of red blood cells present per volume of leukocyte layer. The amount of time that leukocyte layer 820 is subjected to Rotational movement in the centrifuge container 10 can be Maximize as follows. First, it feeds whole blood 800 to the first container channel 420 when the centrifuge container 10 is rotating. As explained previously, whole blood 800 is separated in the layer leukocyte 820 and RBC 810 as it rises above the plate lower 300. The second container channel 410 and the third channel of container 740 are then closed. The entrance of blood integer 800 continues until the separation volume 220 is filled with a combination of leukocyte layer 820 near the part top and RBC810 near the bottom of the container centrifuge 10. Removing RBC 810 from centrifuge container 10 by the second container channel 410 only, a volume is created additional for the entrance of whole blood 800 and the layer leukocyte not extracted 820 is subjected to rotational forces for a prolonged period of time. Since the container of centrifuge 10 keeps turning, part of RBC 810 that may be trapped in leukocyte layer 820, they are pushed to the side bottom of centrifuge container 10 and away from the third channel of container 740 and leukocyte layer 820. Thus, when it is opened the third container channel 740, the leukocyte layer 820 that is removed, has a lower% HCT. Controlling the entrance fee 800 whole blood and leukocyte layer exit rates 820 and RBC 810, you can achieve a constant state that produces a leukocyte layer 820 with approximately constant HCT%.

Elimination of discontinuous processing and better yields achieved by the present invention have reduced treatment time needed to treat properly patients. For an adult of medium build, there are that capture 90-100 milliliters of layer leukocyte / white blood cells in order to perform a treatment of complete photophoresis. To collect this amount of layer leukocyte / white blood cells, the present invention has to process about 1.5 liters of whole blood. The amount needed white blood cell / white blood cells can be taken from 1.5 liters of whole blood approximately in 30-45 minutes using the present invention, collecting about 60% or more of the total amount of the layer leukocyte / white blood cells that undergo the process of separation. Leukocyte layer / captured white blood cells have an HCT of 2% or less. In comparison, an existing device, the UVAR XTS, it takes about 90 minutes to process 1.5 liters of blood whole to get enough layer leukocyte / white blood cells. The UVAR XTS only collects around 50% of the total amount of the layer leukocyte / white blood cells that undergo the process of separation. HCT of the leukocyte layer / white blood cells collected by the UVAR XTS is around 2%, but not substantially lower. Another existing device, the Cobe Spectra ™ from Gambro, must process 10 liters of whole blood in order to collect enough layer leukocyte / white blood cells. This typically takes around 150 minutes, collecting only 10-15% of the total amount of white blood cell / white blood cell layer undergo the separation process, and that has an HCT of about 2% Thus, it has been discovered that while the existing devices and systems require 152 to 225 minutes to separate, process, treat, and reinfuse the necessary amount of white blood cells or leukocyte layer, the present invention can Perform the same functions in less than 70 minutes. This times They do not include patient preparation or priming time. The times indicate only the total time the patient is connected to the system

Claims (8)

1. An apparatus including a cassette (1100) for control the movement of blood and blood components separate, including the cassette (1100): a rigid plastic housing (1101); flexible tube loops (1120-1124) leaving the accommodation (1101); flexible tubes (1106-1119) other than loops that extend to, inside and outside the accommodation (1101); Y at least three exposed tube sections flexible inside the housing (1101) exposed on one side of the housing (1101) so that fluid flow to through an exposed section when pressure is exerted on the exposed section selected from the exposed side; where the side of the accommodation (1101) where the hoses are exposed including holes (1137, 1157) to through which pressure can be exerted on the sections exposed; Y the housing (1101) has an opposite side that includes a molded occluder bar (1173), the occluder bar being adapted to resist the pressure exerted in order to close each selected section of tubes between the hole (1157) and the opposite side of the housing to thereby prevent the flow of fluid through the selected sections of tubes, characterized in that the occluder bar crosses the exposed section of three of the flexible tubes. 2. The apparatus of claim 1 having a hub (1140) inside the housing (1101) adapted to connect Flexible tube sections. 3. The apparatus of claim 2 wherein the hub (1140) is adapted to connect five sections of tubes flexible 4. The apparatus of any of the claims 1 to 3 wherein the rigid plastic housing (1101) has an upper section and a lower section that form jointly an internal space, including the lower section the hole (1157) to access the three sections of flexible tube exposed. 5. The apparatus of any of the claims 1 to 4 having five tube loops and six holes 6. The device of any of the claims 1 to 5 wherein the housing (1101) has a section upper and a lower section that together form a space internal, including the bottom section the hole (1157) for access the exposed flexible tube sections, looking at the bar molded occluder (1173) on the side of the section above the internal space and in front of the hole (1157), the cassette (1100) adapted to allow at least one actuator to close selectively the flow of fluid in the exposed section of a tube flexible by pressing the flexible tubes through the hole and against the molded occluder bar (1173). 7. The device of any of the claims 1 to 6 having a fluid communication filter With at least one flexible tube. 8. The device of any of the claims 1 to 7 having six holes (1137, 1157) in the lower section, corresponding molded edges (1163, 1173) in the upper section in front of the holes (1137, 1157), and at minus a section of flexible tubes between each hole and each molded edge; five tube loops; and a cube (1140) adapted to connect five tube sections.